10818. SPECIAL EXEMPTIONS

10818 SPECIAL EXEMPTIONS 10818.1 Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in Table 1 of § 10804. The request must specify each requirement from which an exemption is requested. In addition to other information that is required, the justification must contain documented evidence showing that the product or product type for which the exemption is requested does not pose a public health risk and meets at least one (1) of the following criteria: The products cannot emit electronic product radiation in sufficient intensity or of such quality, under any conditions of operation, maintenance, service, or product failure, to be hazardous; The products are produced in small quantities; The products are used by trained individuals and are to be used by the same manufacturing corporation or for research, investigation, or training; The products are custom designed and used by trained individuals knowledgeable of the hazards; or The products are produced in such a way that the requirements are inappropriate or unnecessary. 10818.2 The Director may, subject to any conditions that the Director deems necessary to protect the public health, exempt manufacturers from all or part of the record and reporting requirements of this part on the basis of information submitted in accordance with § 10818.1 of this section or such other information which the Department may possess if the Department determines that such exemption is in keeping with the purposes of the Act. 10818.3 The Department will provide written notification of the reason for any denial. If the exemption is granted, the Department will provide written notification of: (a) The electronic product or products for which the exemption has been granted; (b) The requirements from which the product is exempted; and (c) Such conditions as are deemed necessary to protect the public health and safety. Copies of exemptions shall be available upon request from the Department. 10818.4 The Department may exempt certain classes of products from the reporting requirements listed in Table 1 of § 10804, provided that the Department finds that such exemption is in keeping with the purposes of the Act. 10818.5 Manufacturers of products for which there is no applicable performance standard and for which an investigational device exemption has been approved or for which a premarket approval application has been approved in accordance with § 10611.4 of this chapter are exempt from submitting all reports listed in Table 1 of § 10804. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10818