Rule 3745-570-211 | Approval criteria for issuance of an alternative infectious waste treatment technology approval.
(A) Approval criteria. The director may approve an application for an alternative infectious waste treatment technology only if the director determines the following:
(1) The applicant complies with paragraph (A) of rule 3745-570-210 of the Administrative Code.
(2) The use of the alternative treatment technology is protective of human health, safety, and the environment.
(3) The applicant has demonstrated that the alternative treatment technology is capable of attaining the performance standard for treatment specified in rule 3745-570-210 of the Administrative Code.
(B) Alternate infectious waste treatment approval. At a minimum, an approval for an alternative infectious waste treatment technology shall include the following:
(1) A description of the alternative treatment technology and its design and a notice that any changes to the design render the approval inapplicable.
(2) The treatment parameters for operating the treatment unit during the treatment of infectious waste and the requirements for continuous monitoring of those treatment parameters.
(3) A requirement that the applicant include an operating manual with each distributed treatment unit that includes a copy of the approval letter.
(4) The operational procedures to be followed by the owner and operator during the use of the alternative treatment technology including any prohibitions of specific categories of infectious wastes.
(5) A biological challenge testing and validation testing obligation to ensure that the alternative treatment technology is achieving the applicable performance standard for treatment.
(6) Record keeping requirements, which may include but are not limited to treatment parameters, monitoring documentation, and biological challenge testing results.
(7) Measures to be utilized to manage infectious waste in the event that the alternative treatment technology fails to achieve the performance standard for treatment specified in rule 3745-570-210 of the Administrative Code.
(8) Any other conditions or requirements that the director deems appropriate in order to ensure that the approved alternative treatment technology will be capable of achieving the performance standard for treatment specified in rule 3745-570-210 of the Administrative Code and that the treatment technology will be capable of being operated in a manner that is protective of human health, safety, and the environment.
(9) A statement that the approval authorizes the use of the alternative treatment technology only when both of the following are satisfied:
(a) The alternative treatment technology is designed as set forth in the approval.
(b) The alternative treatment technology is used to treat only the types and volumes of waste streams that were tested in accordance with rule 3745-570-212 of the Administrative Code and for which testing results were provided as part of the application.
(10) A description of the types and volumes of waste streams for which the alternative infectious waste treatment technology has been tested against in accordance with rule 3745-570-212 of the Administrative Code.
(C) The director may deny an application for an alternative infectious waste treatment technology if any of the following occur:
(1) Not later than one hundred eighty days after being notified of deficiencies, the applicant has not corrected noted deficiencies and resubmitted the application.
(2) The applicant has notified Ohio EPA that the application is being withdrawn.
(3) Any of the approval criteria set forth in paragraph (A) of this rule have not been satisfied.
(4) The applicant has not demonstrated sufficient reliability, expertise, and competency to operate an infectious waste treatment technology in a manner that is protective of human health, safety, and the environment.
(D) Revocation. The director may revoke any alternative infectious waste treatment technology approval when any of the following has occurred or is likely to occur:
(1) The use or operation of the alternative infectious waste treatment technology has resulted or is likely to result in a violation of any applicable law.
(2) The application contained false or incorrect information.
(3) Under actual operation, the technology consistently fails to attain the performance standard for treatment as specified in rule 3745-570-210 of the Administrative Code.
(4) The applicant has changed the design of the approved technology such that the equipment no longer meets the originally submitted specifications.
(5) The use of the technology causes or threatens to adversely affect, or has adversely affected human health, safety, or the environment.
(6) The applicant does not exhibit sufficient reliability, expertise, and competency to operate the infectious waste treatment technology in a manner that is protective of human health, safety, and the environment.
(7) The applicant failed to timely submit an analysis required by rule 3745-570-213 of the Administrative Code.
(8) The analysis submitted pursuant to rule 3745-570-213 of the Administrative Code demonstrates that the alternative infectious waste treatment technology no longer meets the performance standard for treatment under this chapter.
(E) Notwithstanding any other provision of this chapter, when issuing, denying, or revoking an alternative infectious waste treatment technology approval, the director may consider the actual performance history of a technology that has been used or approved for use outside of Ohio.
Last updated April 7, 2025 at 8:06 AM
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