N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.6

Current through Register Vol. 46, No. 45, November 2, 2024

Section 365-2.6 - General treatment requirements

In addition to the requirements in section 365-2.5 of this Subpart, a RMW treatment facility must comply with the following criteria:

(a) Except as provided in subdivisions (b) and (c) of this section, treatment of RMW must be by:

(1) discharge into a sanitary sewer system connected to a secondary treatment facility, if the waste is liquid or semi-solid, except as specifically prohibited by the NYSDOH, or by local law or ordinance;

(2) incineration in a RMW incineration facility regulated under Subpart 362-1 of this Title;

(3) decontamination or inactivation by autoclaving in conformance with the requirements of this Subpart;

(4) decontamination by discharge to an effluent decontamination system approved by the department; or

(5) an alternative RMW treatment system approved by the NYSDOH.

(b) Restrictions on autoclave use

(1) An autoclave cannot be used for treatment of RMW containing or mixed with hazardous waste and/or pharmaceuticals.

(2) An autoclave cannot be used for treatment of radiological RMW unless decayed to a background radiation level or the facility set alarm for radiation levels prior to treatment.

(3) An autoclave cannot be used for treatment of recognizable human organs or body parts, or animal body parts or carcasses unless in small quantities, and approved by the department, or provided the NYSDOH has approved the autoclave model as an alternative treatment technology for those wastes.

(4) An autoclave cannot be used for treatment of thermally resistant materials such as solidified liquids or bulk animal bedding having a volume of more than five cubic feet unless approved by the department and NYSDOH as an alternative treatment system.

(5) An autoclave cannot be used for the treatment of toxins of biological origin unless autoclaving can be verified by identifying the scientific source documenting it as an effective and appropriate method for inactivating biological toxins or the method used for inactivating toxins of biological origin is one of those listed by the Centers for Disease Control and Prevention in the "Biosafety in Microbiological and Biomedical Laboratories" publication as incorporated by reference in section 360.3 of this Title.

(c) Cultures and stocks

(1) Cultures and stocks containing select agents or non-exempt quantities of toxins of biological origin listed in 7 CFR Part 331, 9 CFR Part 121 and 42 CFR part 73 as incorporated by reference in section 360.3 of this Title, must be treated on-site by incineration, autoclaving, use of an alternative treatment system approved by the NYSDOH, or inactivation in accordance with the Federal Select Agent Program. However, if the generating facility does not have a predictable need for on-site treatment and the waste is incidental to the delivery of medical care or research, the generating facility can arrange for transportation of the select agents and toxins of biological origin to a facility authorized by the department to treat the waste. If the waste is shipped off-site for treatment, the generator must comply with federal regulations regarding possession, use and transfer of select agents and toxins of biological origin found in 7 CFR Part 331, 9 CFR Part 121 and 42 CFR part 73 as incorporated by reference in section 360.3 of this Title.

(2) Cultures and stocks containing infectious agents other than those referenced in paragraph (1) of this subdivision may be transported off-site for treatment.

(d) Discarded sharps must be destroyed prior to disposal. Sharps that have not come into contact with infectious agents do not need to be treated.

(e) Treatment facilities must have a response plan in place to be followed in the event the facility is notified or discovers that RMW has left the facility without required treatment.

(f) Treated RMW can be disposed of as MSW at a combustor, landfill or other disposal facility authorized by the department to accept RMW after treatment.

(g) Treated RMW must be accompanied by a NYSDOH certificate of treatment.

(h) Effective treatment of RMW. Treatment of RMW must be demonstrated by no growth in viable 'G. stearothermophilus' spore concentration, or other biological indicator or measure of effectiveness acceptable to the department. In addition:

(1) for infectious agents including certain vegetative bacteria, fungi, lipophilic and hydrophilic viruses, parasites, mycobacteria, and similar organisms, no growth is required;

(2) for human tissues, human organs, or animal waste body parts, the treatment must render the waste visually unrecognizable;

(3) for sharps, the treatment must render the sharps unusable; and

(4) for toxins of biological origin, the decontamination, inactivation and treatment must inactivate the toxin.

(i) Validation testing prior to equipment use. Prior to using an RMW treatment system, the facility must conduct validation testing. Written approval of validation and repeat validation test protocols and test results must be obtained from the department prior to acceptance of RMW for treatment. The department must be notified before all validation testing is conducted, review and approve the scientific source documenting it as effective.

(1) The testing must include three separate treatment runs in accordance with the following requirements:

(i) the operational parameters used during the tests must be consistent with the parameters that will be used during routine operation of the treatment process (e.g., cycle duration, heat, chemical, or irradiation exposure time, chemical concentration, or other treatment parameters, etc.);

(ii) for autoclaves, each test must document removal of all air from the autoclave and include one or more pre-vacuum cycles or depending on the autoclave one or more steam pulses;

(iii) the RMW composition (e.g., porosity, liquids, solids, organic matter, thermal resistance and type of packaging etc.) and load configuration (e.g., packing density, orientation etc.) during the tests must be consistent with the waste properties and loading process during routine operation; and

(iv) the moisture content (i.e., wet or dry) and volume of the waste during the tests must be consistent with the waste that will be treated during routine operation.

(2) To assess treatment performance, the system must employ commercially-prepared biological indicators from the same lot or batch, each containing spores of 'Geobacillus stearothermophilus' (for steam, or moist heat, or hydrogen peroxide systems), 'Bacillus atropheus' (for dry heat or chemical systems) or an organism that demonstrates the necessary resistance for the treatment method, as determined by the department. The indicators must:

(i) have a minimum concentration of 6 log 10 spores. The concentration must be higher and more thermally resistant than the bioburden routinely associated with the waste;

(ii) include a supplier's certificate of performance that identifies the organism (genus, species, strain and population) and, for thermal treatment systems, the D-value and the Z-value. The D-value must be 1.8 minutes and the Z-value must be no less than 50 degrees Fahrenheit (10 degrees Celsius);

(iii) be appropriate for the type of RMW and device (i.e., self-contained, suspension or paper strip), including the shelf life, the carrier material and primary packaging, the culture medium for self-contained biological indicators and the media, growth and culture conditions for non-self-contained biological indicators;

(iv) be compatible with the treatment process and have a resistance relative to the temperature, pressures, conditions, chemicals or irradiation used in the process, the infectious agents on a substrate, the type and density of the waste to be treated and its packaging;

(v) be placed throughout the RMW load during each validation test, including at the coldest point in the treatment system. The department may also require alternative and/or supplemental indicators (e.g., thermocouples, etc.) to demonstrate chemical saturation, heat penetration or irradiation exposure and effectiveness of treatment;

(vi) comply with the following number of biological indicators in each validation test load:

(a) three biological indicators per cycle for 0-110 pounds of RMW per load;

(b) five biological indicators per cycle for 111-550 pounds of RMW per load;

(c) seven biological indicators per cycle for 551-1100 pounds of RMW per load;

(d) nine biological indicators per cycle for 1101-1650 pounds of RMW per load;

(e) 11 or more, as determined by the department, biological indicators per cycle for any treatment system greater than 1650 pounds of RMW per load; and

(f) one or more controls from the same lot or batch;

(vii) be wrapped in a paper towel and encased in cotton batting or in another carrier system designed to mimic the thermal resistance in the RMW before placement into the package to be treated with the RMW. Materials used to hold the indicator units must be similar to the RMW to be treated, provide effective protection from breakage, be loose in the bulk of the RMW and be easily retrievable at the end of each validation run; and

(viii) be wrapped in a thick layer of cotton, wool, or equivalent to prevent direct conduction of heat from the metal if metal containers are used to contain the indicators.

(3) Biological indicators requiring microbial bioassay to confirm efficacy must be quantitatively analyzed after the treatment cycle. All self-contained biological indicators used for test runs must be qualitatively analyzed for color change following incubation.

(4) Unless otherwise approved by the department, the laboratory used to analyze the results of the validation test must be independent of the facility owner or operator. No less than one-third of the biological indicators used during each validation test run must be analyzed by an independent laboratory.

(5) The system must employ process monitoring concurrent with biological indicators, including devices and instrumentation to record temperature and/or other critical operating parameters.

(6) Verification testing for commercially purchased biological indicators. Each lot or batch of biological indicators with a stated population must be tested prior to use at the facility. Each verification test must use a minimum of three indicators from the same lot or batch that must be sent to an independent laboratory.

(7) All commercially-purchased biological indicators must be stored in accordance with the manufacturer's specifications.

(8) Commercially-purchased indicators in the form of paper strips must not be used in devices or areas where fluids can pool or puddle around the biological indicator. Self-contained biological indicators with vent caps must not be used where liquids may accumulate and contaminate the indicators.

(j) Repeat validation testing. Validation testing must be repeated when any of the following occurs. The department must be notified before validation occurs.

(1) failure of any treatment process operational parameters such as time, temperature, or pressure during validation;

(2) failure to achieve microbial inactivation and treatment in at least 95 percent of the biological indicators during each treatment cycle during validation;

(3) any modifications to the treatment process operational parameters;

(4) a treatment device has been operational without a repeat validation for at least five years; or

(5) the treatment device has not been used for at least one year.

(k) RMW treatment system operation requirements

(1) The facility must use controls appropriate for the treatment system (e.g., real time monitoring devices that record process feed rate or flow, cycle time, pressure, temperature, pH, chemical or irradiation levels, etc.).

(2) Biological monitors (e.g., thermochemical indicators and integrators such as autoclave tape, paper strips or small ampoules, thermocouples, wireless data loggers, etc., or other monitors suitable for the treatment technology) must be placed in or on the outside of RMW containers and distributed throughout the load, chamber, or vessel during treatment.

(3) Bio-challenge testing is required with each load for biocontainment facilities at BSL 3 or 4.

(4) Loading devices must be automated or, if mechanical, designed and operated to maintain the integrity of the container being loaded into a treatment device.

(5) Process control instruments must be maintained in operable condition. All process instruments must be calibrated at the intervals recommended by the manufacturer, but not less than once per year.

(6) A general facility inspection must be undertaken at least annually to determine the operating condition of the process and control equipment. The annual inspection must be performed by a qualified individual such as a certified industrial hygienist or biosafety specialist, or a licensed professional engineer not affiliated with the facility. The results of the inspection must be included in the annual report.

(7) All emptied reusable RMW containers must be appropriately washed and disinfected after each use and facility equipment used for handling and processing the waste must be cleaned and decontaminated whenever it is visibly soiled or contaminated.

(8) If a treatment system fails to operate in accordance with the permitted and acceptable operating parameters (time, temperature, pressure, or chemical concentration), or if more than 5% of the biological indicators used during the treatment cycle fail or show growth, the facility must:

(i) discontinue use of the system, using emergency shutdown procedures if appropriate, until corrective action has been taken and then repeat the treatment cycle. Repeat validation or bio-challenge testing must be performed to verify that effective treatment can resume;

(ii) ensure that all RMW that was processed by the system since the last run when the unit was in compliance, is identified as untreated RMW and document that the RMW was properly retreated;

(iii) document the failure, including date and system identifier;

(iv) document the facility response, including corrective action; and

(v) whenever a facility has reason to believe untreated RMW certified as treated RMW has left the facility, notify the waste transporter, the receiving facility, and the department as soon as practicable.

(l) An operation log must be maintained for each treatment device. The log must record the date, time, name of operator, the type and amount of RMW treated, operating parameters, and the dates and results of calibration and testing. These records may be maintained electronically.

(m) Sharps consolidation. Sharps consolidation prior to treatment must be conducted as follows.

(1) Reusable sharps containers processed at the facility must be processed with an automated or mechanical delidder and dumping system. Lids may not be removed manually.

(2) Reusable sharps containers and transport cages must be mechanically cleaned with an appropriate disinfectant prior to reuse.

(3) Reusable sharps containers must be approved by the USFDA for reuse.

(4) Reusable sharps containers removed from service must be managed as RMW or, if proposed to be recycled, cleaned and decontaminated.

(5) All reusable containers, including sharps containers, must be tested using bio-challenge tests on an annual basis, in a manner approved by the department.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.6

Adopted New York State Register September 20, 2017/Volume XXXIX, Issue 38, eff. 11/4/2017

Amended New York State Register June 7, 2023/Volume XLV, Issue 23, eff. 7/22/2023

Amended New York State Register June 21, 2023/Volume XLV, Issue 25, eff. 7/23/2023