Rapid Precision Testing Laboratories, Cordova, TN, USA.
Health Phys. 2011 Sep;101(3):227-32. doi: 10.1097/HP.0b013e3182166490.
The authors compared calculations of sunlamp maximum exposure times following current USFDA Guidance Policy on the Maximum Timer Interval and Exposure Schedule, with USFDA/CDRH proposals revising these to equivalent erythemal exposures of ISO/CIE Standard Erythema Dose (SED). In 2003, [USFDA/CDRH proposed replacing their unique CDRH/Lytle] erythema action spectrum with the ISO/CIE erythema action spectrum and revising the sunlamp maximum exposure timer to 600 J m(-2) ISO/CIE effective dose, presented as being biologically equivalent. Preliminary analysis failed to confirm said equivalence, indicating instead ∼38% increased exposure when applying these proposed revisions. To confirm and refine this finding, a collaboration of tanning bed and UV lamp manufacturers compiled 89 UV spectra representing a broad sampling of U.S. indoor tanning equipment. USFDA maximum recommended exposure time (Te) per current sunlamp guidance and CIE erythemal effectiveness per ISO/CIE standard were calculated. The CIE effective dose delivered per Te averaged 456 J(CIE) m(-2) (SD = 0.17) or ∼4.5 SED. The authors found that CDRH's proposed 600 J(CIE) m(-2) recommended maximum sunlamp exposure exceeds current Te erythemal dose by ∼33%. The current USFDA 0.75 MED initial exposure was ∼0.9 SED, consistent with 1.0 SED initial dose in existing international sunlamp standards. As no sunlamps analyzed exceeded 5 SED, a revised maximum exposure of 500 J(CIE) m(-2) (∼80% of CDRH's proposal) should be compatible with existing tanning equipment. A tanning acclimatization schedule is proposed beginning at 1 SED thrice-weekly, increasing uniformly stepwise over 4 wk to a 5 SED maximum exposure in conjunction with a tan maintenance schedule of twice-weekly 5 SED sessions, as biologically equivalent to current USFDA sunlamp policy.
作者比较了根据当前美国食品和药物管理局（USFDA）关于最大计时器间隔和暴露时间表的指导政策以及美国食品和药物管理局/CDRH 对这些政策的修订，以计算出太阳灯的最大暴露时间，使其等效于 ISO/CIE 标准红斑剂量（SED）的红斑暴露。2003 年，[美国食品和药物管理局/CDRH 提议用 ISO/CIE 红斑作用光谱取代其独特的 CDRH/Lytle]红斑作用光谱，并将太阳灯最大暴露定时器修订为 600Jm(-2)ISO/CIE 有效剂量，提出的理由是生物等效。初步分析未能证实这种等效性，反而表明，应用这些建议的修订会增加约 38%的暴露量。为了确认和完善这一发现，一批晒黑床和紫外线灯制造商合作，汇编了 89 个代表美国室内晒黑设备广泛采样的紫外线光谱。根据当前的太阳灯指导和 ISO/CIE 标准，计算了每盏灯的美国食品和药物管理局最大推荐暴露时间（Te）和 CIE 红斑功效。Te 期间，CIE 有效剂量的平均值为 456J（CIE）m(-2)（SD=0.17）或约 4.5SED。作者发现，CDRH 提议的 600J（CIE）m(-2)最大太阳灯推荐暴露量比当前 Te 红斑剂量高约 33%。目前，美国食品和药物管理局的初始暴露量为 0.75MED，约为 0.9SED，与现有的国际太阳灯标准中 1.0SED 的初始剂量一致。由于没有分析的太阳灯超过 5SED，因此修订后的最大暴露量应为 500J（CIE）m(-2)（约为 CDRH 提议的 80%），与现有的晒黑设备兼容。作者提出了一个晒黑适应计划，从每周三次 1SED 开始，在 4 周内均匀逐步增加到每周两次 5SED 的最大暴露量，同时结合每周两次 5SED 的晒黑维持计划，与当前的美国食品和药物管理局太阳灯政策生物等效。
