Section 22-B10320. MAXIMUM ACCEPTABLE LEVEL OF OZONE

 

10320.1Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.

 

10320.2Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs, resulting in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure. Thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration.

 

10320.3A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated or misbranded if it is used or intended for use under the following conditions:

 

(a)In such a manner that it generates ozone at a level in excess of five hundredths (0.05) parts per million by volume of air circulating through the device or causes an accumulation of ozone in excess of five hundredths (0.05) parts per million by volume of air (when measured under standard conditions at twenty-five degrees Celsius (25 ºC), seventy-seven degrees Fahrenheit (77 ºF), and seven hundred sixty millimeters (760 mm.) of mercury in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices.  This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product;

 

(b)To generate ozone and release it into the atmosphere in hospitals or other establishments occupied by the ill or infirm;

 

(c)To generate ozone and release it into the atmosphere and does not indicate in its labeling the maximum acceptable concentration of ozone which may be generated (not to exceed five-hundredths (0.05) parts per million by volume of air circulating through the device) as established herein and the smallest area in which such device can be used so as not to produce an ozone accumulation in excess of five-hundredths (0.05) parts per million;

 

(d) In any medical condition for which there is no proof of safety and effectiveness; or

 

(e)To generate ozone at a level less than five-hundredths (0.05) parts per  million by volume of air circulating through the device and it is labeled for  use as a germicide or deodorizer.

 

10320.4This section does not affect the present threshold limit value of one tenth (0.10) part per million (two tenths of a milligram per cubic meter (0.2 mg./m.3)) of ozone exposure for an eight (8)-hour-day exposure of industrial workers as the American Conference of Governmental Industrial Hygienists recommend.

 

10320.5The method and apparatus specified in 40 C.F.R., part 50, or any other equally sensitive and accurate method, may be employed in measuring ozone pursuant to this section.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).