NYC Indoor Tanning Regulations C. Boyd 10.28.14
Transcription
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.