CONTENT OF GENERAL PERMITS AND WAIVERS OR MODIFICATIONS
§ 284.121. Contents of general permits.
Each general permit issued by the Department will include, at a minimum:
(1) A clear and specific description of the category of processing of regulated medical or chemotherapeutic waste eligible for coverage under the general permit.
(2) The standards in § 284.101(a) (relating to authorization for general permits) and a brief explanation of the reasons for the Department’s determination that the category of processing is eligible for coverage under the general permit in accordance with the standards in § 284.101(a).
(3) A specification of registration requirements established in accordance with § 284.131 (relating to authorization for persons or municipalities to be included in a general permit) and the fee imposed on registrants for coverage under the general permit.
(4) An effective date, and a fixed permit term, which may not exceed 10 years from the effective date. If the Department renews a general permit, the term may not exceed the term of the original permit.
(5) A set of terms and conditions governing the construction, operation, maintenance, inspection and monitoring of the processing activities covered by the general permit as are necessary to assure compliance with this act, this article and the environmental protection acts.
(6) A requirement that persons or municipalities who conduct activities authorized by the general permit shall allow authorized representatives of the Commonwealth, without advance notice or a search warrant, upon the presentation of appropriate credentials, and without delay, to have access to areas in which the activities covered by the general permit will be, are being or have been conducted to ensure compliance with the act and the act of July 13, 1988 (P. L. 525, No. 93) (35 P. S. § § 6019.1—6019.6), known as the Infectious and Chemotherapeutic Waste Law, regulations promulgated thereunder and a permit, license or order issued by the Department under the act.
(7) A requirement that the activities authorized by the general permit will not harm or present a threat of harm to the health, safety or welfare of the people or environment of this Commonwealth.
(8) A requirement that waste be accompanied by a properly completed log or shipping paper, in accordance with Subchapter H (relating to tracking of regulated medical and chemotherapeutic waste).
(9) A requirement that waste be delivered by a licensed transporter in accordance with Subchapter G (relating to transporter licensing for regulated medical and chemotherapeutic waste), when appropriate.
(10) A requirement that the processing facility operate in accordance with local, State and Federal requirements.
(11) A requirement that the processing residue be managed in accordance with the Solid Waste Management Act (35 P. S. § § 6018.101—6018.1003) and the regulations promulgated thereunder.
(12) A requirement that an up-to-date list of names, addresses and telephone numbers of employees that have been designated by the permittee to respond to emergencies at the processing facility be maintained at the facility.
(13) A requirement that individual employee training records be maintained at the processing facility.
(14) A requirement for use of additional indicators selected by the Department to monitor the disinfection process.
(15) A requirement that daily records of the weight or volume of the waste processed, the method and location of disposal facilities for wastes from the processing facility and waste handling problems and emergencies be maintained for 3 years.
(16) A requirement that a log be maintained for each disinfection unit for 3 years that records the following:
(i) The date, time and operator for each use.
(ii) The dates and results of calibration.
(iii) The results of biological indicator spore testing.
(iv) Other information that the Department may require relating to the disinfection process.
(17) Requirements for closure.
(18) A prohibition against processing pathological waste or chemotherapeutic waste in an autoclave.
Source The provisions of this § 284.121 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273299) to (273300).
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