ISSUANCE OF A GENERAL PERMIT
§ 284.111. Application for general permit.
(a) A person or municipality may apply to the Department for the issuance of a general permit for a specific category of processing of regulated medical or chemotherapeutic waste.
(b) An application for the issuance of a general permit for processing regulated medical or chemotherapeutic waste shall be submitted on a form prepared by the Department and shall contain the following:
(1) A description of the waste.
(2) A characterization of the waste as either regulated medical or chemotherapeutic.
(3) An operation plan which contains the following:
(i) A description of the proposed processing activity and equipment.
(ii) A description of the method proposed to receive regulated medical or chemotherapeutic waste which ensures the waste is handled separately from other solid waste until processing and disposal, and that prevents unauthorized persons from having access to or contact with the waste.
(iii) A description of the procedure for managing containers which arrive in a leaking condition, which includes whether the waste is processed immediately, repacked or rejected.
(iv) A description of the method proposed to unload and process regulated medical or chemotherapeutic waste, limiting the number of persons handling the waste and minimizing the possibility of exposure of that waste to employees and the public using or visiting the facility.
(v) A description of the method proposed for disinfecting emptied, reusable regulated medical waste containers, transport vehicles and facility equipment which are known or suspected to be contaminated with regulated medical waste.
(vi) A description of the method proposed for handling and disposal of regulated medical or chemotherapeutic waste containers which cannot be reused.
(vii) A description of reuse of containers if the surfaces of the containers have been protected from direct contact with chemotherapeutic waste.
(viii) A description of the means by which provisions will be made to require the use of clean gloves and clean uniforms along with other protective clothing to provide protection of employees against exposure to regulated medical or chemotherapeutic waste.
(ix) A description of the means by which provisions will be made to require decontamination of a person having had bodily contact with regulated medical or chemotherapeutic waste while handling that waste at the facility.
(x) A description of the method proposed to quantify, on a weight basis, the maximum amount of regulated medical or chemotherapeutic waste to be stored and processed each month.
(xi) A schedule of the operating hours of the facility.
(xii) A description of the method proposed to assure that regulated medical or chemotherapeutic waste received at the facility is consistent with § 283.201 (relating to basic limitations).
(xiii) A description of periodic testing using biological indicators which demonstrate effective disinfection of the waste, in accordance with § 284.321 (relating to regulated medical waste monitoring requirements).
(xiv) A description of closure activities which are proposed to be carried out upon cessation of operations, in accordance with § 283.272 (relating to cessation of operations).
(xv) A description of how the processing residue will be managed.
(xvi) A description of how aerosols will be minimized and controlled during processing activities.
(4) A contingency plan which provides procedures to be used for emergency situations including, at a minimum, spills of regulated medical or chemotherapeutic waste and ruptures of containers containing the waste. The plan shall include procedures for cleanup and disinfection of spill area, protection of personnel, disposal of spill residue and repackaging of the waste. The plan shall also include a description of an alternative waste handling system during periods when the proposed facility is not in operation, including procedures to be followed in the case of equipment breakdown. Alternate waste handling procedures may include use of standby equipment, extension of operating hours and contractual agreements for diversion of regulated medical or chemotherapeutic waste to other facilities.
(5) A personnel training plan which describes the hiring of equipment operators and the training of personnel involved in the handling and processing of regulated medical or chemotherapeutic waste. The plan shall include a detailed explanation of the operation and contingency plans.
(c) A nonrefundable fee in the form of a check payable to the ‘‘Commonwealth of Pennsylvania’’ for $1,000 shall accompany the application.
(d) The application requirements in subsection (b) may be waived or modified for the mixing of disinfection products with regulated medical waste to perform processing.
Source The provisions of this § 284.111 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial apges (273294) to (273296).
Cross References This section cited in 25 Pa. Code § 284.101 (relating to authorization for general permits); and 25 Pa. Code § 284.114 (relating to approval or denial of an application).
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