No. 33145 (Amendment): Rule R315-316. Infectious Waste Requirements

(Amendment)

DAR File No.: 33145
Filed: 11/12/2009 03:23:00 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The rule addresses the treatment, storage, transportation, and disposal of infectious waste. Changes to the rule are made to make the language clear as to who is affected by the rule and to make the rule consistent with current approved operating practices of disposal facilities.

Summary of the rule or change:

Several changes are made in the rule to clarify applicability and readability. A new definition of sharps is added. The time allowed for storage of infectious waste is increased from 30 to 60 days. Requirements that are addressed in other rules are removed. A pressure, as well as a temperature requirement is added. Mycobacterium bovis is removed as a required test bacterium. Landfill disposal procedures are modified to allow more flexibility.

State statutory or constitutional authorization for this rule:

• Section 19-6-105

Anticipated cost or savings to:

the state budget:

No costs or savings are anticipated as the state does not operate any infectious waste treatment, storage, transportation, or disposal facilities. The changes will not increase or decrease the load on state regulatory agencies.

local governments:

No costs or savings are anticipated as local governments do not operate any infectious waste treatment, storage, or transportation facilities. Any disposal facilities operated by local government may experience a decrease in costs as a result of the increased time allowed for storage prior to disposal. Landfills may experience a very small decrease in cost of disposal resulting from the increased flexibility. The cost savings in both instances will be small and cannot be quantified.

small businesses:

A small business that transports, stores, treats, or disposes of infectious waste will have some minor savings in costs resulting from tracking and maintaining records. Some minor savings will also result for the increase in storage time allowed. The reduction in the required bacteria to be used in testing the effectiveness of treatment methods will result in some minor savings in the cost of treatment studies. The actual cost savings are likely to be small and cannot be quantified but would be less $1,000 per year per business.

persons other than small businesses, businesses, or local governmental entities:

A person that transports, stores, treats, or disposes of infectious waste will have some minor savings in costs resulting from tracking and maintaining records. Some minor savings will also result for the increase in storage time allowed. The reduction in the required bacteria to be used in testing the effectiveness of treatment methods will result in some minor savings in the cost of treatment studies. The actual cost savings are likely to be small and cannot be quantified but would be less $1,000 per year.

Compliance costs for affected persons:

A small business or person that transports, stores, treats, or disposes of infectious waste will have some minor savings in costs resulting from tracking and maintaining records. Some minor savings will also result for the increase in storage time allowed. The reduction in the required bacteria to be used in testing the effectiveness of treatment methods will result in some minor savings in the cost of treatment studies. The actual cost savings are likely to be small and cannot be quantified but would be less $1,000 per year for each business or person affected.

Comments by the department head on the fiscal impact the rule may have on businesses:

A small business or person that transports, stores, treats, or disposes of infectious waste will have some minor savings in costs resulting from tracking and maintaining records. Some minor savings will also result for the increase in storage time allowed. The reduction in the required bacteria to be used in testing the effectiveness of treatment methods will result in some minor savings in the cost of treatment studies. The actual cost savings are likely to be small and cannot be quantified but would be less $1,000 per year for each business or person affected.

Amanda Smith, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Environmental Quality
Solid and Hazardous Waste
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Ralph Bohn at the above address, by phone at 801-538-6794, by FAX at 801-538-6715, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/31/2009

This rule may become effective on:

01/15/2010

Authorized by:

Dennis Downs, Director

RULE TEXT

R315. Environmental Quality, Solid and Hazardous Waste.

R315-316. Infectious Waste Requirements.

R315-316-1. Applicability.

(1) The standards of Rule R315-316 apply to:

(a) any health facility [as defined by Subsection 19-6-102(10)] that generates more than 200 pounds, per month, of infectious waste[as defined by Subsection 19-6-102(12)];

(b) any transporter that collects and transports more than 200 pounds of infectious waste in any one load; and

(c) a [storage, treatment, or disposal] facility storing more than 200 pounds of infections waste, or a facility treating or disposing of infectious waste.

(2) The standards of Rule R315-316 do not apply to

(a) [a]any health facility that generates 200 pounds, or less, of infectious waste per month[.];

(b) any transporter that:

(i) collects and transports 200 pounds or less of infectious waste from all generators in any one load; or

(ii) collects infectious waste only from facilities that generate 200 pounds or less of infectious waste per week; and

(c) infectious waste generated by a household.

 

R315-316-2. General Operational Requirements.

(1) Every owner and operator of a health facility or a transporter of infectious waste, regulated by Rule R315-316, that generates, transports, stores, treats, or disposes of infectious waste must prepare and maintain on file a management plan for the waste that identifies the:

(a) type and estimated quantity of waste generated or handled;

(b) segregation, packaging, and labeling procedures;

(c) collection, storage, and transportation procedures[, including the name of the transporter, to be implemented];

(d) treatment or disposal methods that will be used[, and disposal facility that will be used]; and

(e) the person responsible for the management of the infectious waste.

(2) [All infectious waste generators and handlers shall report any delivery of unauthorized waste to the local health department immediately upon recognition.

(3)] Infectious waste consisting of recognizable human anatomical remains including human fetal remains shall be disposed by incineration or interment in a location appropriate for human remains.

(3) For the purposes of Rule R315-316 "sharps" means any object that may be contaminated with a pathogen and that is capable of cutting or penetrating skin or a packaging material.

 

R315-316-3. Storage and Containment Requirements.

(1) [Containment]Infectious waste shall be contained in a manner and location which affords protection from animal intrusion, does not provide a breeding place or a food source for insects or rodents, and minimizes exposure to the public.

(2) Unless all waste is considered infectious and labeled as such, infectious waste shall be segregated by separate containment from other waste during storage.

(3) Except for sharps, infectious waste shall be contained in plastic bags or inside rigid containers. The bags shall be securely tied and the containers shall be securely sealed to prevent leakage or expulsion of solid or liquid wastes during storage[,] or handling[, or transport].

(4) Sharps shall be contained for storage, transportation, treatment, and disposal in leak-proof, rigid, puncture-resistant containers which are taped closed or tightly lidded to preclude loss of contents.

(5) All [containers used for containment of any] infectious waste [shall]containers should be red or orange[, or if containers are not red or orange,] and shall be clearly identified with the international biohazard sign and one of the following labels: "INFECTIOUS WASTE", "BIOMEDICAL WASTE", or "BIOHAZARD".

(6) If other waste is placed in the same container as infectious waste, then the generator must package, label, and mark the container and its entire contents as infectious waste.

(7) A rigid infectious waste container may be reused for infectious or non-infectious waste if it is thoroughly washed and decontaminated each time it is emptied or if the surfaces of the container have been completely protected from contamination by disposable, unpunctured, or undamaged liners, bags, or other devices that are removed with the infectious waste,[ and] the surface of the liner has not been damaged or punctured.

(8) Storage and containment areas shall: protect infectious waste from the elements; be ventilated to the outside atmosphere; be[ only] accessible only to authorized persons; and be marked with prominent warning signs on, or adjacent to, the exterior doors or gates. The warning signs shall contain the international biohazard sign and shall state: "CAUTION -- INFECTIOUS WASTE STORAGE AREA -- UNAUTHORIZED PERSONS KEEP OUT" and must be easily read during daylight from a distance of 25 feet.

(9) If infectious waste is stored longer than seven days, [it]the infectious waste shall be stored at or below a temperature of 40 degrees Fahrenheit (5 degrees Celsius)[, or below].

(10) Under no conditions may infectious waste be stored for longer than [30]60 days.

(11) Compactors, grinders, or similar devices shall not be used to reduce the volume of infectious waste [before the waste has been rendered non-infectious ]unless the device is contained sufficiently to prevent contamination of the surrounding area.

 

R315-316-4. Infectious Waste Transportation Requirements.

(1) Infectious waste shall not be transported in the same vehicle with other waste unless the infectious waste is contained in a separate, fully enclosed leak-proof container within the vehicle[ compartment] or unless all of the waste is to be treated as infectious waste in accordance with [this section]Rule R315-316.

(2) Persons manually loading or unloading containers of infectious waste onto or from transport vehicles shall:

(a) be trained in the proper use of protective equipment;

(b) have available and easily accessible at all times puncture resistant gloves and shoes, shatterproof glasses, and coveralls; and

(c) shall have face shields and respirators available[ as deemed necessary by the transporter].

(d) Protective gear that becomes soiled with infectious waste shall be decontaminated or disposed as infectious waste.

(3) Surfaces of transport vehicles that have contacted spilled or leaked infectious waste shall be decontaminated by procedures approved by the Executive Secretary.

(4) [Transport vehicles]Vehicles transporting infectious waste shall meet all warning requirements of the Department of Transportation related to infectious, biohazardous or biomedical waste.

(5) Each truck, trailer, or semitrailer, or container used for transporting infectious waste shall be [so] designed and constructed, and its contents limited , so that under conditions normally incident to transportation, there shall be no releases of infectious waste to the environment.

(6) Any truck, trailer, semitrailer, or container used for transporting infectious waste shall be free from leaks, and all discharge openings shall be securely closed during transportation.

(7) No person shall transport infectious waste into the state for treatment, storage, or disposal unless the waste is packaged, contained, labeled and transported in the manner required by this section.

(8) All transporter vehicles shall carry a spill containment and cleanup kit and the transport workers shall be trained in spill containment and cleanup procedures.

 

R315-316-5. Infectious Waste Treatment and Disposal Requirements.

(1) Infectious waste shall be treated or disposed as soon as possible [but not to exceed 30 days after generation,] and shall be treated or disposed at a facility with a permit or other form of approval allowing the facility to treat or dispose infectious waste.

(2)(a) All material that has been rendered non-infectious through an approved treatment method may be handled as non-infectious solid waste, provided it is not otherwise a hazardous waste or a radioactive waste excluded from disposal in a solid waste facility by [Rule R315-316]Rules R315-301 through 320.

(b) Except for incineration and steam sterilization, no treatment method may be used to render materials non-infectious without receiving prior approval from the Executive Secretary.

(3) Infectious waste may be incinerated in an incinerator provided the incinerator is permitted or approved under Rules R315-301 through 320.[

(a) The incinerator shall comply with the requirements of Rule R315-306 and provide complete combustion of the waste to carbonized or mineralized ash.

(b) A composite sample of the ash and residues from the incinerator shall be taken at least once each year. The sample shall be analyzed by the U.S. EPA Test Method 1311 as provided in 40 CFR Part 261, Appendix II, 1991 ed., Toxic Characteristics Leaching Procedure (TCLP) on parameters determined by the Executive Secretary to determine if it is a hazardous waste. If hazardous, it shall be managed by applicable state regulations.]

(4) Infectious waste may be sterilized by heating in a steam sterilizer to render the waste non-infectious.

(a) The operator shall have available , and shall certify in writing that he understands , written operating procedures for each steam sterilizer, including time, temperature, pressure, type of waste, type of container, closure [on]of container, pattern of loading, water content, and maximum load quantity.

(b) Infectious waste shall be subjected to sufficient temperature, pressure and time to inactivate Bacillus stearothermophilus spores in the center of the waste load at a 6 Log ₁₀ reduction or greater.

(c) Unless a steam sterilizer is equipped to continuously monitor and record temperature and pressure during the entire length of each sterilization cycle, each package of infectious waste to be sterilized shall have a temperature[ ] -sensitive tape or equivalent test material, such as chemical indicators, attached that will indicate if the sterilization temperature and pressure have been reached. Waste shall not be considered sterilized if the tape or equivalent indicator fails to indicate that a temperature of at least 250 degrees Fahrenheit (121 degrees Celsius) was reached and a pressure of at least 15 psi was maintained during the process.

(d) Each sterilization unit shall be evaluated for effectiveness with spores of B. stearothermophilus at least once each 40 hours of operation or each week, whichever is less frequent.

(e) A written log for each load shall be maintained for each sterilization unit which shall contain at a minimum:

(i) the time of day[,] and the date[,] of each load and the operator's name;

(ii) the amount and type of infectious waste placed in the sterilizer; and

(iii) the temperature , pressure, and duration of treatment.

(5)(a) Alternative treatment methods may be approved on a site-specific basis when the Executive Secretary finds the proposed alternative treatment method renders the material non-infectious.

(b) The determination shall be based on the results of laboratory tests, submitted by the person proposing the use of the treatment method, meeting the following requirements:

(i) the laboratory tests shall be conducted:

(A) by qualified laboratory personnel;

(B) using recognized microbial techniques;

(C) on samples that have been inoculated with the test organisms, then subjected to the proposed treatment method and processed [the same way as will be used in]in an identical way to the treatment process [if approved]being proposed for approval; and

(ii) the results of the tests must document that the proposed treatment method inactivates:

(A) vegetative bacteria - Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15442) at a 6 Log ₁₀ reduction or greater (a 99.9999% reduction or greater of the organism population);

(B) fungi - Candida albicans (ATCC 18804), Penicillium chrysogenum (ATCC 24791), or Aspergillus niger at a 6 Log ₁₀ reduction or greater;

(C) viruses - Polio 2, Polio 3, or MS-2 Bacteriophage (ATCC15597-B1) at a 6 Log ₁₀ reduction or greater;

(D) parasites - Cryptosporidium spp. oocysts or Giardia spp. cysts at a 6 Log ₁₀ reduction or greater;

(E) mycobacteria - Mycobacterium terrae[,]or Mycobacterium phlei[, or Mycobacterium bovis (BCG) (ATCC 35743)] at a 6 Log₁₀ reduction or greater; and

(B) Bacterial spores - Bacillus stearothermophilus spores (ATCC 7953) or Bacillus subtilis spores (ATCC 19659) at a 4 Log ₁₀ reduction or greater (a 99.99% reduction or greater of the organism population).

(iii) The Executive Secretary shall review the submitted materials and reply in writing within 30 days of the receipt of the [submittal]treatment studies.

(6) Infectious waste may be discharged to a sewage treatment system that provides secondary treatment of waste but only if the waste is liquid or semi-solid and if approved by the operator of the sewage treatment system.

(7) Infectious waste may be disposed in a permitted Class I, II, or V Landfill. Upon entering the landfill, the transporter of infectious waste shall notify the landfill operator that the load contains infectious waste. The landfill operator shall abide by the following procedures in the disposition and covering of infectious waste:

(a) place the infectious waste containers [at the bottom of]in the working face with sufficient care to avoid breaking them;

(b) completely cover the infectious waste immediately with a minimum of 12 inches of earth or waste material containing no infectious waste; and

(c) not compact the infectious waste until completely covered with 12 inches of earth or waste material containing no infectious waste.

 

KEY: solid waste management, waste disposal

Date of Enactment or Last Substantive Amendment: [February 1, 2007]2010

Notice of Continuation: February 14, 2008

Authorizing, and Implemented or Interpreted Law: 19-6-105

 

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