NYC Indoor Tanning Regulations C. Boyd 10.28.14

New York City Department of Health
Indoor Tanning Regulations
Reducing Exposure to High Intensity UV:
Stringent Regulation and
Effective Risk Communication
Christopher Boyd
Assistant Commissioner, Bureau of Environmental Sciences and Engineering
Office of Radiological Health
Conference of Environmental Health Directors
October 28, 2014
BIG QUESTIONS
1) How do we quantify population level risks associated with exposure to
high intensity UV radiation?
2) Regulatory Innovation:
• What would improve operation and safety of equipment delivering high
intensity UV radiation to the public?
• How can we address risks associated with excessive exposures?
• How can we address false and misleading statements from the indoor
tanning industry?
• How can we expedite local and state jurisdictions to adopt more
stringent approaches?
3) What is the most effective public health risk communication?
4) How can we influence the FDA to update risk based standards for UV
equipment?
INDOOR TANNING CREATES
POPULATION LEVEL RISKS
Established Industry
• Wide range of manufacturers that continue to develop new
ways to deliver high intensity UV radiation equipment to
public and businesses
• 25,000 free standing facilities + 20,000 business
establishments offering tanning services. 1
• Industry revenue over $5 billion 2
INDOOR TANNING CREATES
POPULATION LEVEL RISKS
Nationally, Millions Access Routinely
• Adolescent Girls (14-17yrs): 17% report tanning in the last 12
months ≈ 1.4 Million. 3
• Adults18-29 yrs: 11% report tanning at least once in the past 12
months ≈ 5.6 Million. 4
• Young white females (16-25 yrs): 30-40% report tanning in the
past year ≈ 4.75 Million. 5
High Frequency of Use
• Marketing strategies aimed at facilitating overexposure
(“Unlimited”, “All-you-can-tan”)
• 60% of those who have tanned in the last year report tanning at
least 10 times during that period. 5
INDOOR TANNING CREATES
POPULATION LEVEL RISKS
New York City Youth Risk Behavior Survey (2013)*
• Public High School Students: 8.8% report tanning at least once in
the last 12 months ≈ 18,100
• Reported illegal use, by youth ≤ 16 years: 8.6% ≈ 13,200.
• Reported use requiring parental consent (17 years): 8.4% ≈ 3,400.
• Males report higher rate of tanning (9.5%) than females (7.9%).
High Frequency of Use
• Approx. number of total tanning sessions by NYC youth in the last
12 months: 144,500 to >237,200
• Approx. number of illegal tanning sessions (≥16 yrs.) in the last 12
months: 104,400 to >164,900
• Approx. number of tanning sessions requiring parental consent
(17 yrs.) in the last 12 months: 27,200 to >49,800
Data are weighted to the NYC public high school student population, excluding students in special education, alternative, and transfer schools, and
schools where >30% of students are ELL.
SOME IN INDUSTRY PERPETUATE
MYTHS AND MISINFORMATION
US FTC issued complaint and entered into Consent Order with Indoor
Tanning Association (ITA) in 2010. ITA shall not represent, endorse, or
claim19:
• Indoor tanning does not increase the risk of skin cancer
• Tanning is safe or poses no danger
• Indoor tanning is approved by the government
• Indoor tanning is safer than tanning outdoors
NYS AG made similar complaint against Hollywood Tans franchise
(NYC, NY, NJ) in 2014. In addition to the above requirements, HT
shall not20:
• Use the term “unlimited” to describe of promote tanning services
• Utilize or reference high school proms in any advertising, replace
“student” with “college student” in all advertising
EXPOSURE TO HIGH INTENSITY
UV INCREASES RISK OF CANCER
• Carcinogenic: as classified by WHO and HHS. 6
• Melanoma: 75% greater risk of melanoma for adult tanners
who began tanning indoors before the age of 35. 7
• Dose-Response: demonstrated “strong” relationship between
melanoma risk and indoor tanning (total hrs, sessions or years)
and that melanoma risk is increased 1.8% with every additional
tanning session. 8
• Carcinoma: twice as likely to develop squamous cell
carcinoma for those who have ever used a tanning bed.
9
• Acute Injury: at least 1,800 annual emergency room visits are
related to device use, 60% of young indoor tanners reported
experiencing burns after exposure sessions 10
HIGH SOCIETAL COSTS OF
MELANOMA
• Over 9,000 deaths per year, 7th most common form of cancer
(US Adults, 2010)11
- New York City: 3.6% Average Annual Increase in Incidence
(2002-2011), 110 deaths per year (average 2007-2011)12
• Annual Health Care Costs: estimated $1.7 billion in Treatment
+ $3.8 billion in lost productivity.13
• Incidence consistently rising: across all age groups (including
young adults)14
CURRENT RISK PREVENTION EFFORTS
FDA warning language
Facility licensing
Federal taxation
Operator training
Age bans for minors
Unsupervised tanning bans
Informed consent Advertising to minors’ bans Operator minimum age
What Is Proven Successful?
•
Youth restriction regulations: shown to reduce youth access to indoor
tanning15
Success Contingent on How Implemented
•
Risk Communication: 90% percent of college tanners had adequate
knowledge of skin cancer risk from tanning, but still proceeded to
tan.16
•
Regulatory Approach: varying enforcement efforts and high rates of
noncompliance. 17
NEW YORK CITY’S REGULATORY
APPROACH
Build Upon NYS Baseline 
Ranked “Moderate” on tanning regulation
“stringency matrix”18
•
•
•
•
•
•
2-year permit of all tanning facilities, unannounced biennial inspection
Age ban for minors ≤16 years old, parental consent for 17 year olds
Devices electrical system safely installed
Devices must be properly labeled (FDA-approved)
Remote (lock-out) timers for all devices, manual shut-offs for patrons,
timer testing
Protective eyewear used, provided at no additional cost
(continued on next slide)
NEW YORK CITY’S REGULATORY
APPROACH
Build Upon NYS Baseline 
Ranked “Moderate” on tanning regulation
“stringency matrix”18
•
•
•
•
•
•
•
Injury/Illness reporting required
Patron record kept for each visit including date, duration and device
Hazards information sheet, and patron acknowledgement form
Warning Signs, required language and required placement
Equipment maintenance record kept for 2-years
Adequate UV lamps and filters
Devices properly sanitized with disinfectant after each use
NEW YORK CITY’S REGULATORY
APPROACH
Improve upon Baseline 
“Moderate” to “Very Strong”
Adopt other State’s “Strong” regulations:
• Operator Training Requirements (FL, LA, NC, OH, OR, etc.)
• Age-Ban Declarative signage in lobby (OR)
• Maximum operating temperature, 100° (KS, UT, DC, OR)
NEW YORK CITY’S REGULATORY
APPROACH
Innovate  Regulate Tanning as
Delivery of High-Intensity UV Radiation
Authorized to measure compliance with FDA emission standards
• Irradiance ratio limit (200-260nm / 260-320nm < 0.003)
• Maximum exposure times, as established by FDA guidance
• Maximum exposure times based on manufacturer
recommended schedules
Potential to evaluate exposure/risk of patron through detailed tracking
• Patron records must include machine used, dose generated,
minutes of exposure for every tanning session, total expected
exposure
Example of NYC’s portable spectroradiometer
PATRONS DO NOT RECALL
CURRENT RISK MESSAGES ON
WARNING SIGNS
Focus Group Testing on Warning Labels and Signs:
• FDA: modifying current language and format, “may more
effectively convey [the] risks [of indoor tanning] than the
current labeling requirements,” 21
• NYC: warnings not noticed, message not received
“If it’s there, I've never seen the signs.” (Women, age 18-30)
“There might be something on top of the bed, like before you
close it, but I'm not looking there.” (Men, age 18-40)
EXAMPLE OF WARNING
MESSAGE NOT RECEIVED
Visibility (Focus Groups Testing)
“I don’t think the sign would catch my attention.”
(Women, age 18-30)
“You can’t even barely read it from a distance. (Men,
age 18-40)
“I would walk by it and not even notice it.” (Women,
age 18-40)
Message
“It’s potentially dangerous, not that it is
dangerous.” (Women, age 18-30)
“But they say “overexposure.” It’s like,
“Overexposure doesn’t apply to me.” (Women,
age 18-30)
Current NYS State Sign
(posted at every device)
RISK COMMUNICATION
THAT WORKS
High Visibility Message 
Graphic Photographic Examples
(Focus Groups Testing)
“Powerful, striking, dramatic.” (Women, age 18-40)
“I think it’s pretty effective, especially with the visuals.”
(Women, age 18-30)
“I’m like really in shock right now! I mean, I knew all
this, but putting pictures, I’m like, ‘Oh my God. What
am I doing to myself?’” (Women, age 18-30)
“I feel like when it’s tangible and you can see it, that it
makes a huge difference. When you just read
something, you’re like, eh, but when you see effects, it
makes a bigger difference.” (Women, age 18-30)
New York City Sign, posted at every device
RISK COMMUNICATION
THAT WORKS
Message Comprehension 
Clear & Concise Risk Language
“You can very clearly understand the consequences of tanning.”
(Men, age 18-40)
“The most important stuff, the directives, like certain
medications and cosmetics may increase your risk of severe
damage is better than injury. Starting off with “follow
instructions carefully” is like too weak.” (Women, age 18-30,
Mix Exposure)
“Just one thing about the wording. I don't know if it’s legal or
illegal not to wear eyewear while you’re tanning. And I feel
like if it’s by law you have to wear eyewear, I think it would
be effective for that to be included.” (Women, age 18-40,
Regular Exposure)
“It is short and sweet. You can read the four points. (Men, age
18-40, Mix Exposure)
“Bulleting it makes clear points” (Women, age 18-30, Mix
Exposure)
New York City Sign, detail
PROVIDE RISK INFORMATION
BEFORE EXPOSURE TO HIGH
INTENSITY UV
Health Risk Handout:
Clear Warning Message
Actionable Direction  “Protect Yourself”
Clear Warning Message
Actionable Direction
Clear Warning Message
Actionable Direction
NYC Brochure
(given to every
first-time patron)
CAPTURE PATRON INFORMATION
TO ASSESS EXPOSURE
Record conformance to FDA approved
manufacture's recommended exposure schedule
Skin type + Device make/model + recent tanning history =
manufacturer's recommended exposure time
Collect information to assess accumulated exposure
Verify staff assisting patron is trained and follows
exposure requirements
Skin Type
Device
First Exposure /
Established Tan
Recommended
Schedule
NYC Patron
Record (filled our
for every patron
visit)
Track
accumulated
exposure
SUMMARY
• Indoor tanning should be regulated based on the risk
presented to public health
• State and local jurisdictions (Radiation Control
Programs) are leading the effort to understand and
respond to population level risks
• Robust discussion of federal role in oversight of
equipment and establishing dose to risk relationship is
needed
-
Device Classification (I vs II) and Performance Standard
-
Risk based exposure schedules (tan maintenance vs.
skin burn vs. cancer risk)
SOURCES
1.
Indoor Tanning Association. Indoor Tanning Association home page http://www.theita.com/
2.
Looking Fit (2010) Facts and Figures. http://www.lookingfit.com//articles/2009/05/the-state-of-the-industry-report-2008.aspx
3.
Mayer et al. Adolescents’ Use of Indoor Tanning: A large-scale evaluation of psychosocial, environmental, and policy-level correlates. American Journal of Public health.
2011 May: 101(5). Population estimated based on US Census 2013 National Population Dataset, accessed: https://www.census.gov/popest/data/datasets.html
4.
Hartman et al. Use of Indoor Tanning Devices by Adults – United State 2010. Morbidity and Mortality Weekly Report. May 11, 2012: 61(18). Population estimated based on
US Census 2013 National Population Dataset, accessed: https://www.census.gov/popest/data/datasets.html
5.
Guy et al. Indoor Tanning Among Young Non-Hispanic White Females. JAMA Internal Medicine. August 19, 2013. Population estimated based on US Census 2013 National
Population Dataset, accessed: https://www.census.gov/popest/data/datasets.html
6.
IARC, 2009. See also; Dennis K. Woo and Melody J. Eide. Tanning Beds, Skin Cancer, and Vitamin D: An Examination of the Scientific Evidence and Public Health
Implications, Dermatologic Therapy, 2010
7.
IARC, 2009
8.
Lazovich et al. Indoor tanning and risk of melanoma: a case-control study in a highly exposed population. Cancer epidmiol Biomarkers Prev. June 2010: 19(6): 1557-1568;
Boniol et al. Cutaneous melanoma attributable to sunbed use. BMJ. 2012: 345:e4757 .
9.
IARC, 2009
10.
National Electronic Injury Surveillance System, CDC. Reported on FDA website: http://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm116447.htm ; Cokkinides et al. Indoor Tanning among Adolescents in the US,
1998 to 2004. Cancer, January 2009.
11.
U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2010 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2013
12.
New York State Cancer Registry. Trends Using the Joinpoint Regression Program with up to Four Jointpoints (1976-2011); accessed:
http://www.health.ny.gov/statistics/cancer/registry/pdf/apc.pdf Cancer Incidence and Mortality for New York City, 2007-2011. NYSDOH: 2013. Accessed:
http://www.health.ny.gov/statistics/cancer/registry/vol1/v1rnyc.htm
13.
Bickers DR, Lim HW, Margolis D, et al. The burden of skin diseases: 2004: a joint project of the American Academy of Dermatol ogy Association and the Society for
Investigative Dermatology. J Am Acad Dermatol 2006;55(3):490–500
14.
Jemal et al. Recent trends in cutaneous melanoma incidence and death rates in the United States, 1992 -2006. J Am Acad Dermatol 2011: 65(5).
15.
Hester et al. Compliance with youth access regulations for indoor UV tanning. Arch. Dermatol. 2005: Vol. 141.
16.
Knight et al. Awareness of the risks of tanning lamps does not influence behavior among college students. Arch Dermatol. 2002: Vol. 138.
17.
Watson et al. Preventing Skin Cancer Through Reduction of Indoor Tanning: Current Evidence. American Journal of Preventative Medicine. 2013;44(6): 682-689.
18.
Gosis et al. Comprehensive Evaluation of Indoor Tanning Regulations: A 50 -State Analysis, 2012. Journal of Investigative Dermatology (2012)134.
19.
United States of America Federal Trade Commission. Agreement Containing Consent Order, In the Matter of Indoor Tanning Assoc iation. File No. 082-3159. January 26,
2010.
20.
Attorney General of the State of New York Health Care Bureau. Assurance of Discontinuance Pursuant to New York Executive Law Section 63, Subdivision 15, In the Matter
of HT Franchising Management (dba “Hollywood Tans”) and HT Acquisition Holdings, LLC. Assurance No. 13 -486. March 27 th , 2014.
21.
US FDA. Report to Congress: labeling information on the relationship between the use of indoor tanning devices and developmen t of skin cancer of other skin damage. 2007.