Ala. Admin. Code r. 335-17-6-.01

Current through Register Vol. 43, No. 1, October 31, 2024

Section 335-17-6-.01 - Treatment Measures

Medical waste intended for transport to a solid waste disposal facility shall be treated on-site or at some alternative location prior to disposal When written certification is required by the Department or the permittee of the disposal facility to be utilized on a per load basis, the person treating the medical waste shall provide the transporter the certification The certification must state that all regulated medical waste has been treated prior to placing the waste in a designated location for transport to an approved disposal facility When written certification is required on a less frequent basis as noted above, the responsible person for the treatment facility shall provide the certification to the permittee or his designee of the disposal facility to be utilized.

(1)Incinerators. Persons owning or operating an incinerator (combustion unit) shall comply with the ADEM requirements in 335-3 regarding air pollution control.

(a) Storage requirements for untreated medical waste located at the incinerator facility shall comply with 335-17-4-.01.

(b) Storage requirements for the ash residue collected at the incinerator facility shall comply with 335-17-4-.02.

(c) Transportation of the ash or other solid waste which is not classified as untreated medical waste shall comply with 335-17-5-.02.

(d) All combustible medical waste shall be rendered during incineration or further processed prior to disposal. Additional processing may include grinding or shredding to render the waste unrecognizable.

(e) Disposal of ash and other solid waste generated at an incinerator or combustion unit used to treat medical waste shall comply with 335-13-4-.22.

(2)Steam Sterilizers. Persons owning or operating a commercial medical waste facility used to treat medical waste by steam sterilization shall apply for a permit within 90 days of the effective date of this Division. After the effective date of this Division, a person shall not start operating a new facility of this type without obtaining a valid permit from the Department. Medical waste may be treated by steam sterilizers (autoclaves) provided the following requirements are met:

(a) Medical waste containing hazardous chemicals, or radioactive waste shall not be approved for this method of treatment.

(b) Certain medical waste, including sharps and recognizable human tissue, organs, body parts, and infected animals, shall be further processed after the steam sterilization process.

1. The additional processing methods for sharps includes, but is not limited to, grinding, incineration, or packaging in puncture proof containers.

2. The additional processing methods for recognizable human tissue, organs, and body parts includes, but is not limited to, incineration, grinding and/or interment. The method selected must render the waste unrecognizable prior to containment for shipment to a disposal facility, or place of interment.

(d) Steam sterilizers should be equipped to continuously monitor and record temperature and pressure during the entire length of each cycle. Sterilizers not so equipped shall affix a temperature sensitive tape to each bag or container or obtain approval from the Department of an equivalent test.

1. Each bag or container shall be exposed to a minimum temperature of 2 50 degrees Fahrenheit and at least 15 pounds of pressure for 3 0 minutes. Processing requirements may be altered if proper decontamination is assured by appropriate testing, and approval is received from the Department.

2. Each sterilizer shall be evaluated for effectiveness under full loading by an approved method at least once for each 40 hours of combined operation. Biological indicators such as spores of "Bacillus stearothemophilus" may be utilized with Departmental approval.

(e) A written log or other means of documentation as approved by the Department shall be maintained for each steam sterilization unit and shall contain the following:

1. The date, time (including duration), and operator for each cycle;

2. Approximate weight or volume of medical waste treated during each cycle;

3. The temperature and pressure maintained during each cycle;

4. Method utilized for confirmation of temperature and pressure; and

5. Dates and results of calibration and maintenance.

(f) Packaging of medical waste which has been treated by steam sterilization shall comply with the requirements contained in 335-17-3-.02.

(g) Owners or operators of steam sterilizers shall not place untreated regulated medical waste in areas or containers designated for pickup and delivery to a solid waste disposal facility.

(h) Sterilizers utilized for waste treatment shall not be utilized for sterilization of equipment, food, or other related items.

(3) Other treatment methods may be approved by the Department which are consistent with the intent of this Division. A person must make a request in writing for approval of an alternative treatment method and shall address the following minimum requirements:

(a) Storage requirements for untreated medical waste shall comply with 335-17-4-.01.

(b) Storage requirements for treated medical waste shall comply with 335-17-4-.02.

(c) Transportation of untreated medical waste shall comply with 335-17-5-.01.

(d) Transportation of treated medical waste shall comply with 335-17-5-.02.

(e) Specific types of medical waste and projected volumes shall be stated.

(f) A demonstration that the alternative treatment method provides protection for the public and the environment equal to that provided by methods contained in 335-17-6-.01(l) and (2).

(g) A demonstration of the effectiveness of the proposed treatment method.

Ala. Admin. Code r. 335-17-6-.01

New Rule: Filed December 12, 2011; effective January 16, 2012.

Author: James L. Bryant

Statutory Authority:Code of Ala. 1975, §§ 22-27-9, 22-27-12.