Section 526.12. Treatment facilities.

 

(1)   Licenses. Except as provided in sub. (2) , no person may operate or maintain an infectious waste treatment facility unless the person has obtained an operating license from the department under s. NR 502.08 as a solid waste processing facility and the facility meets all the requirements in this chapter for containing, handling, storing and treating infectious waste. To apply for an operating license, the applicant shall do all of the following:

(a) Contact the department's district or area office as appropriate to arrange an initial site inspection for the purpose of evaluating compliance with the requirements of s. NR 502.08 (3) .

(b) Prepare a plan of operation as described in sub. (3) .

(c) Submit the plan of operation to the department for approval, according to the requirements in s. NR 500.05 . Upon receipt of the plan of operation, the department shall send an invoice for the plan review fee for solid waste processing facilities, as specified in s. NR 520.04 , Table 2.

(d) After obtaining a plan of operation approval from the department, submit an application form for the operating license and the license fee for a solid waste processing facility, according to ss. NR 500.06 and 520.04 , Table 2.

(2)   Exemptions. Persons who operate the following infectious waste treatment facilities are exempt from the requirements for obtaining an operating license and submitting a plan of operation for a solid waste processing facility, but shall comply with the following specified requirements:

(a) Individual infectious waste treatment facilities which are located on the property where the infectious waste was generated and which treat less than 500 pounds of infectious waste per day. These treatment facilities may accept infectious waste from other infectious waste generators if the waste is accepted on a not-for-profit and cost-only basis. Persons operating these infectious waste treatment facilities shall follow all the requirements in sub. (4) for operating and testing the treatment unit and for keeping records.

(b) Incinerators and municipal solid waste combustors, which are regulated under s. NR 502.09 or 502.13 . In addition to what is required under those sections, persons operating incinerators and municipal solid waste combustors shall follow the requirements in sub. (4) (a) and (c) for operating an infectious waste treatment unit and for keeping records.

(3)   Plan of operation. Except as provided in sub. (2) , no person may establish or construct an infectious waste treatment facility or expand an existing facility unless the person has met the applicable requirements of s. NR 502.08 for solid waste processing facilities and has obtained from the department a plan of operation approval and applied for an operating license as a solid waste processing facility. The plan of operation shall specify the intent and objectives of the proposal and indicate methods and procedures to prevent and minimize adverse environmental and health impacts. Unless otherwise approved by the department in writing, the plan shall be submitted in accordance with s. NR 500.05 and shall contain, at a minimum, the information listed in s. NR 502.08 (3) to (5) and any other details necessary to address the requirements in this chapter, including but not limited to requirements for handling, containment and storage and the requirements in subs. (4) and (5) .

(4)   Minimum requirements for all treatment facilities. No person may operate or maintain an infectious waste treatment facility unless all of the following requirements are met:

(a) Operating. The person shall demonstrate that the treatment unit renders infectious waste non-infectious. The operator shall follow a written operational manual or documented quality assurance procedures for operating the treatment unit. The operational procedures shall be available to the operator at all times the treatment unit is in operation.

(b) Testing. At a minimum, the person shall ensure that a qualified person tests the treatment unit at the frequency specified by the manufacturer's instructions or after every 100 hours of operation, whichever is more frequent. Test methods shall be appropriate for the treatment method and shall be based on medically-accepted procedures and the manufacturer's instructions. Acceptable test methods may be physical, chemical or microbiological in nature, as appropriate for the treatment method.

(c) Keeping records. The person shall maintain an operating log for each treatment unit in the treatment facility and retain the operating log for at least 3 years. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action. For treatment units treating 50 pounds or more of infectious waste per month, the operating log shall be kept for all test cycles and treatment cycles. For treatment units treating less than 50 pounds of infectious waste per month, the operating log shall be kept for test cycles only. The operating log shall contain all of the following information for all test cycles and, if required, treatment cycles:

1. Date.

2. Clock time of start of cycle.

3. Operating parameters, including any of the following that apply to the treatment method being used: temperature, pressure, type of disinfectant, concentration of disinfectant, duration of treatment cycle and contact time.

4. Approximate amount of waste treated by weight, unless this information has already been recorded on an infectious waste manifest or USDOT shipping paper.

5. Generator of waste treated, if other than the owner or operator of the treatment facility, unless the waste is accompanied by an infectious waste manifest or USDOT shipping paper.

6. Results of any tests run to verify disinfection.

(d) Using manifests. Unless USDOT regulations apply, when treating infectious waste which is accompanied by an infectious waste manifest, the operator of an infectious waste treatment facility shall certify that the infectious waste has been treated according to s. NR 526.11 by doing all of the following:

1. The operator shall sign the infectious waste manifest according to s. NR 526.14 (1) (b) .

2. The operator shall send a copy of the signed infectious waste manifest form along with the treated infectious waste to the solid waste disposal facility where the waste is disposed. The department may approve alternative procedures for certifying that waste has undergone infectious waste treatment before being disposed.

3. Within 30 days of when the infectious waste was treated, the operator shall return to the generator the signed original infectious waste manifest form which certifies to the infectious waste generator that the infectious waste has been treated according to s. NR 526.11 . The department may approve alternative procedures for certifying that waste has undergone infectious waste treatment.

(5)   Operating requirements for licensed treatment facilities. In addition to the requirements in sub. (4) , persons who operate infectious waste treatment facilities which are required to be licensed as solid waste processing facilities under sub. (1) shall meet the requirements in ss. NR 502.08 (6) to (8) , 502.04 and 502.05 .

History: Cr. Register, October, 1994, No. 466 , eff. 11-1-94; am. (1) (a), (c), (d), (2) (b), (3), (5), Register, June, 1996, No. 486 , eff. 7-1-96; CR 05-020 : am. (1) (c), (4) (c) 4. and 5., (d) (intro.) and 2. Register January 2006 No. 601 , eff. 2-1-05.