Arizona
Biohazardous
Medical Waste
Background Information
Definition of Biohazardous Medical Waste
Managing Biohazardous Medical Wastes
OSHA Regulations
Contacts
Statutes, Regulations and Guidelines
More Information
Background Information
Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).
Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.
Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.
In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.
OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.
Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.
Definition
of Biohazardous Medical Waste
The definition of biohazardous medical waste is
found in Arizona Administrative
Code Article 14 (AAC R18-13-1401 to 1420). Biohazardous Medical
Waste is composed of one or more of the following:
- Cultures and stocks generated in the diagnosis,
treatment or immunization of a human being or animal or in any
research relating to that diagnosis, treatment or immunization,
or in the production or testing of biologicals.
- Human blood and blood products.
- Human pathologic waste such as discarded organs
and body parts removed from surgery.
- Medical sharps used in animal or human patient
care, medical research, or clinical laboratories.
- Research animal wastes such as animal carcasses,
body parts, and bedding of animals that have been infected with
agents that produce, or may produce, human infection.
Managing Biohazardous Medical
Waste
In Arizona regulations
apply to the following:
- A generator who treats biohazardous medical
waste on site, before disposing of it as treated medical waste,
and to any equipment used for that purpose.
- A generator who contracts with a medical waste
treatment facility for the purpose of treating biohazardous medical
waste.
- A person who transports biohazardous medical
waste and any motor vehicle used for that purpose.
- A medical waste treatment facility operator,
a medical waste treatment facility, and any equipment used for
medical waste treatment.
- A person who generates medical sharps in the
preparation of human remains.
- A person who generates medical sharps in the
treatment of animals.
- A generator of discarded drugs not returned
to the manufacturer.
The following persons
are exempt from the regulations:
- Law enforcement personnel handling biohazardous
medical waste for law enforcement purposes.
- A person in possession of radioactive materials.
- A person who returns unused medical sharps
to the manufacturer.
- A household generator residing in a private,
public, or semi-public residence.
- A generator that separates medical devices
from the medical waste stream that are sent out for re-processing
and returned to the generator.
- A person who sends used medical sharps via
the United States Postal Service or private shipping agent to
a treatment facility.
Packaging
Requirements
A generator who sets
biohazardous medical waste out for collection for off-site treatment
or disposal must package the biohazardous medical waste in either
of the following:
- A reusable container that bears the
universal biohazard symbol and that is:
- Leak-proof on all sides and bottom,
closed with a fitted lid, and constructed of smooth, easily
cleanable materials that are impervious to liquids and
resistant to corrosion by disinfection agents and hot water.
- Used for the storage or transport of
biohazardous medical waste and cleaned after each use unless
the inner surfaces of the container have been protected
by disposable liners, bags, or other devices removed with
the waste. “Cleaning” means agitation to remove visible
particles combined with exposure to hot water, an EPA-approved
chemical disinfectant or any other method that the Department
determines is acceptable.
- A generator must handle any container used
for the storage or transport of biohazardous medical waste that
is not capable of being cleaned as described, or that is disposable
packaging, as biohazardous medical waste.
- A generator must not use reusable containers
for any purpose other than the storage of biohazardous medical
waste.
- A generator must not reuse disposable packaging
and liners and must manage such items as biohazardous medical
waste.
Storage
Requirements
Once biohazardous
medical waste has been packaged for shipment off-site, a generator
must provide a storage area for biohazardous medical waste until
the waste is collected and must comply with both of the following
requirements:
- Secure the storage area in a manner that restricts
access to, or contact with the biohazardous medical waste to
authorized persons
- Display the universal biohazard symbol and
post warning signs worded as follows for medical waste storage
areas: "CAUTION-BIOHAZARDOUS MEDIAL WASTE STORAGE AREA UNAUTHORIZED
PERSONS KEEP OUT"
Beginning at the
time the waste is set out for collection, a generator who stores
biohazardous medical waste must comply with all of the following
requirements:
- Keep putrescible biohazardous medical waste
unrefrigerated if it does not create a nuisance. However, refrigerate
at 40 F or less putrescible biohazardous medical waste kept more
than seven days
- Store biohazardous medical waste for 90 days
or less unless the generator has obtained facility plan approval
under A.R.S. and is in compliance with the design and operational
requirements
- Keep the storage area free of visible contamination
- Protect biohazardous medical waste from contact
with water, precipitation, wind or animals. A generator must
ensure that the waste does not provide a breeding place or a
food source for insects or rodents
- Handle spills by re-packaging the biohazardous
medical waste, re-labeling the containers and cleaning any soiled
surface as prescribed
- If odors become a problem a generator must
minimize objectionable odors and the off-site migration of odors.
A generator may place
a container of biohazardous medical waste alongside a container
of solid waste if the biohazardous medical waste is identified
and not allowed to co-mingle with the solid waste. The storage
area must not be used to store substances for human consumption
or for medical supplies.
On-Site Treatment
of Biohazardous Medical Waste
A person who treats
biohazardous medical waste on site must use incineration, autoclaving,
or an alternative medical waste treatment method that meets the
treatment standards.
Incineration. The
following rules apply to incineration.
A generator who incinerates
biohazardous medical waste on site must comply with all of the
following requirements:
- Obtain a permit if required by the local or
state air quality agency having jurisdiction.
- Reduce the biohazardous medical waste, excluding
metallic items, into carbonized or mineralized ash.
- Determine whether incinerator ash is hazardous
waste as required by hazardous waste rules under A.R.S.
- Dispose of the non-hazardous waste incinerator
ash at a Department-approved municipal solid waste landfill.
Autoclaving. The
following rules apply to autoclaving.
A generator who autoclaves
biohazardous medical waste on site must comply with all of the
following requirements:
- Further process by grinding, shredding, or
any other process, any recognizable animals and human tissue,
organs, or body parts, to render such waste non-recognizable
and ensure effective treatment.
- Operate the autoclave at the manufacturer’s
specifications appropriate for the quantity and density of the
load.
- Keep records of operational performance levels
for six months after each treatment cycle; and keep records of
equipment maintenance for the duration of equipment use that
include the date and result of all equipment calibration and
maintenance.
Alternative Methods. The
following rules apply to alternative methods.
A generator who uses
an alternative treatment method on site must comply with all of
the following requirements:
- Use only alternative treatment methods registered
with the sate of Arizona.
- Further process by grinding, shredding, or
any other process, any recognizable animals and human tissue,
organs, or body parts, to render this waste non-recognizable
and ensure effective treatment.
- Follow the manufacturer’s specifications for
equipment operation.
- Supply upon request the Arizona Departmental
of Environmental Quality registration number for the alternative
medical waste treatment technology and the type of biohazardous
medical waste that the equipment is registered to treat, and
the equipment specifications that include operating procedures
and instructions for maintenance, testing and calibration.
- Maintain a training manual regarding the proper
operation of the equipment.
- Maintain a treatment record consisting of
a log of the volume of medical waste treated and a schedule of
calibration and maintenance performed under the manufacturer’s
specifications.
- Maintain treatment records for six months
after the treatment date for each load treated.
- Maintain the equipment specifications for
the duration of equipment use.
Additional Responsibilities
for On-Site Treatment. A generator must:
- Package the treated medical waste according
to the waste collection agency’s requirements.
- Attach to the package or container a label,
placard, or tag with the following words: “This medical waste
has been treated as required by the Arizona Department of Environmental
Quality standards” before placing the treated medical waste out
for collection as a general solid waste.
- Upon request of the solid waste collection
agency or municipal solid waste landfill, provide a certification
that the treated medical waste meets the standards of the regulations.
- Make treatment records available for Departmental
inspection upon request.
- Handle medical sharps as prescribed in the
regulations.
- A generator of chemotherapy waste, cultures
and stocks, or animal waste must handle that waste as prescribed
in the regulations.
Biohazardous
Medical Waste Transported Off Site for Treatment
A generator of biohazardous
medical waste must:
- Package the waste as prescribed in the Regulations
(see packaging requirements above) before self-hauling or before
setting the waste out for collection by a transporter.
- Obtain a copy of the tracking document signed
by the transporter signifying acceptance of the biohazardous
medical waste. A generator must keep a copy of the tracking
document for one year from the date of acceptance by the transporter. The
tracking document must contain the name and address of the generator,
transporter, and medical waste treatment, storage, transfer,
or disposal facility; the quantity of biohazardous medical waste
collected by weight, volume, or number of containers; the identification
number attached to bags or containers; and the date the biohazardous
medical waste is collected.
- Handle the waste as prescribed in the regulations
if a generator of chemotherapy waste, cultures and stocks, or
a generator of animal waste.
- Handle the waste as prescribed in the regulations
if a generator of medical sharps.
A person must obtain
solid waste facility plan approval from the Department as prescribed
in the regulations to construct any facility that will be used
to store, transfer, treat, or dispose of biohazardous medical waste
that was generated off site. Plan approval must be obtained before
starting construction of the medical waste treatment or disposal
facility.
Transportation
A transporter must
register with the Department in addition to possessing a permit,
license, or approval if required by a local health department,
environmental agency, or other governmental agency with jurisdiction.
A person who transports
biohazardous medical waste must maintain in each transporting vehicle
at all times a transportation management plan consisting of both
of the following;
- Routine procedures used to minimize the exposure
of employees and the general public to biohazardous medical waste
throughout the process of collecting, transporting, and handling
- Emergency procedures used for handling spills
or accidents
A transporter who
accepts biohazardous medical waste from a generator must leave
a copy of the tracking document described in the regulations with
the person from whom the waste is accepted. The document must accompany
the person who has physical possession of the biohazardous medical
waste. Upon delivery, the transporter must obtain a copy of the
tracking document, signed by a person representing the receiving
facility, signifying acceptance of the biohazardous medical waste.
A transporter who
transports biohazardous medical waste in a vehicle dedicated to
the transportation of biohazardous medical waste must ensure that
the cargo compartment can be secured to limit access to authorized
persons at all times except during loading and unloading. In addition,
the cargo compartment must be constructed in compliance with one
of the following:
- Have a fully enclosed, leak-proof cargo compartment
consisting of a floor, sides, and a roof that are made of a non-porous
material impervious to biohazardous medical waste and physically
separated from the driver’s compartment.
- Haul a fully enclosed, leak-proof cargo box
made of a non-porous material impervious to biohazardous medical
waste.
- Tow a fully enclosed leak-proof trailer made
of a non-porous material impervious to biohazardous medical waste.
A person who transports
biohazardous medical waste in a vehicle not dedicated to the transportation
of biohazardous medical waste, but that is used longer than 30
consecutive days, must comply with the Arizona regulations.
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