File No. 33145
This rule was published in the December 1, 2009, issue (Vol. 2009, No. 23) of the Utah State Bulletin.
Environmental Quality, Solid and Hazardous Waste
Rule R315-316
Infectious Waste Requirements
Notice of Proposed Rule
(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 QualitySolid 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 rbohn@utah.gov
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
Additional Information
The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull-pdf/2009/b20091201.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.
Text to be deleted is struck through and surrounded by brackets (e.g., [example]). Text to be added is underlined (e.g., example). Older browsers may not depict some or any of these attributes on the screen or when the document is printed.
For questions regarding the content or application of this rule, please contact Ralph Bohn at the above address, by phone at 801-538-6794, by FAX at 801-538-6715, or by Internet E-mail at rbohn@utah.gov.