LOOK HERE FIRST
This Document Contains a discussion of medical waste issues, Medical
Waste Management Rules.
CONTENTS
·
Sharps
·
Special
Treatment Arrangements
·
Interface With OSHA Regulations
INTRODUCTION
This document is provided to help you understand the North Carolina medical
waste management rules.
If you would like further information, please contact the Solid Waste Section
in the Department of Environment and Natural Resources (DENR). Contact Bill
Patrakis at (336) 771-5091, email: william.patrakis@ncmail.net
You may also contact a local Waste Management Specialist in one of the seven
DENR regional offices.
GENERAL INFORMATION
The Solid Waste Section regulates the packaging, labeling, storage,
transportation, treatment and disposal of medical waste in North Carolina.
Treatment, storage and disposal facilities that accept waste from outside of
the facility cannot operate without a permit from the Solid Waste Section.
Please read this entire document. Due to the complex nature of medical waste
regulations, failure to read this entire document may result in failure to
comply with the rules.
This guide is not intended as legal advice, but as an aid to understanding the
current North Carolina medical waste management rules.
Effective Date
The medical waste
management rules became effective October 1, 1990. The most recent amendments
were made in April 1993.
Enforcement of the Rules
The medical waste
management rules are enforced by the Solid Waste Section and, in some cases,
the local law enforcement authority.
Pre-Emption of Local Solid Waste Laws on
Medical Waste
These rules pre-empt
local solid waste laws on medical waste where local laws are more lenient.
Joint and Several Liability
Under state regulations
a solid waste generator is responsible for the storage, collection and disposal
of his or her solid waste. The generator is responsible for ensuring that solid
waste is disposed at a site or facility that has all applicable permits
required to receive waste. (15A NCAC 13B .0106)
Medical Waste Definition
Medical waste means any
solid waste which is generated in the diagnosis, treatment, or immunization of
human beings or animals, in research pertaining thereto, or in the production
or testing of biologicals, but does not include any hazardous waste identified
or listed pursuant to this Article, radioactive waste, household waste as
defined in 40 Code of Federal Regulations § 261.4(b)(1) in effect on 1 July
1989, or those substances excluded from the definition of solid waste in this
section. (NCGS 130A-290(a)(18)
Regulated Medical Waste Definition
Regulated medical waste
means blood and body fluids in individual containers in volumes greater than 20
ml, microbiological waste, and pathological waste that have not been treated
pursuant to .1207. (.1207 is the definition of treatment - see rules on page
22.) Regulated medical waste must be treated prior to disposal. After treatment
these wastes may be handled as general solid waste. (.1201(9))
Percentage of the Medical Waste Stream That Is Regulated Medical Waste
Most medical waste may
be handled as general solid waste and does not require treatment. Regulated
medical waste makes up only a very small portion of the total medical waste
stream. The percentage of a facility's waste stream comprised of regulated
medical waste is dependant on the activities at that facility. Roughly 9
percent to 15 percent of the waste stream at hospitals is regulated medical
waste. Some facilities, such as long-term care facilities, generate medical
waste but little or no regulated medical waste.
Microbiological Waste
Microbiological waste
means cultures and stocks of infectious agents, including but not limited to
specimens from medical, pathological, pharmaceutical, research, commercial and
industrial laboratories. (.1201(5))
Pathological Waste
Pathological waste
means human tissues, organs and body parts; and the carcasses and body parts of
all animals that were known to have been exposed to pathogens that are
potentially dangerous to humans during research, were used in the production of
biologicals or in vivo testing of pharmaceuticals, or that died of a known or
suspected disease transmissible to humans. (.1201(8))
Blood and Body Fluids
Blood and body fluids
means liquid blood, serum, plasma, other blood products, emulsified human
tissue, spinal fluids and pleural and peritoneal fluids. Dialysates are not
blood or body fluids under this definition. Please note that the definition of
regulated medical waste specifies blood and body fluids that are in a liquid
state and in a container, such as a suction canister. This does not refer to
blood absorbed by materials such as bandages and dressings. (Some waste items
contaminated with blood may be subject to OSHA labeling requirements).
(.1201(1))
Medical Waste Such as Dressings, Bandages, Sponges, Used Gloves, and Tubing
These items are not
included in the definition of regulated medical waste and may be disposed of
without treatment. (.1201(9))
Requirements for Blood and Body Fluids in Individual Containers in
Volumes Equal to or Less Than 20 ml
These "containers" are commonly vacuum tubes used for blood samples.
If not stored in a secured area, accessible only to authorized personnel, these
containers must be packaged either in a container suitable for sharps or in a
plastic bag in a rigid fiberboard box or drum. Treatment is not required prior
to disposal. (.1202(c))
Urine and Feces
Urine and feces should
be disposed of through sanitary sewage or septage disposal practices. Soiled
diapers are not regulated medical waste and may be disposed as general solid
waste.
Registration of Medical Waste Generators
North Carolina does not
require generators of medical waste to register.
Artificial Body Parts and Implants Removed or Replaced During Surgical
Procedures
Items such as
artificial limbs and pacemakers are considered medical waste. However, they are
not generally considered regulated medical waste because they do not fall
within a class of regulated medical waste.
Medical Waste Reduction Techniques
Information about
medical waste reduction techniques is available from the Solid Waste Section
and the Division of Pollution Prevention and Environmental Assistance.
Sharps
.1201(10)
"Sharps" means and includes needles, syringes with attached needles,
capillary tubes, slides and cover slips, and scalpel blades.
Disposal of Sharps
The rules do not require
treatment of sharps before disposal. They must be packaged in a container that
is rigid, leak-proof when in an upright position and puncture resistant. The
package then may be disposed of with general solid waste. (Generators should
comply with any relevant OSHA requirements for labeling and packaging).
(.1202(b))
Compaction of Sharps
Sharps cannot be
processed in small compaction units inside the generating facility. The rule
does not prohibit hauling sharps to the landfill on trucks that compact waste.
Also, it does not prohibit processing sharps containers in large commercial
compactors where the waste will be transported to a disposal facility without
being transferred to another container. (.1202(b))
Sharps Generated in Private Households
Household waste is not
included in the definition of medical waste and is not subject to the medical
waste management rules. However, home users of sharps are urged to place sharps
in hard wall containers before disposal in order to protect garbage collectors
from needlesticks. A few counties have imposed local restrictions on sharps
disposed from private homes. Home healthcare agencies may find it prudent to
assist in proper disposal of sharps used to administer care to patients in
their homes. This is not specifically required by the rules. Used needles from
farms are subject to the rules and are not considered household waste. Such
waste is more similar to veterinary waste than household waste.
Packaging Regulated Medical Waste for
Off-Site Treatment
Regulated Medical Waste
must be packaged in a plastic bag in a rigid fiberboard box or drum in a manner
that prevents leakage of the contents. The outer surface must be labeled with a
biohazard symbol; the words "INFECTIOUS WASTE" or "MEDICAL WASTE";
the date of shipment; and the name, address and phone number of the generator,
transporter, storage facility and treatment facility. The medical waste
management rules do not require a biohazard label on the plastic bag or use of
red bags. However, generators should be aware that OSHA rules may require
labeling of bags containing some types of medical waste. (.1204(a)(1))
Storage of Regulated Medical Waste Prior to Shipment Off Site for Treatment
- All medical waste,
including regulated medical waste, must be stored in a manner so as not to
create a nuisance either by noxious odors or by encouraging the presence of
vermin. Regulated medical waste must be maintained in a non-putrescent state. -
Regulated medical waste must be stored in a manner that maintains the
integrity, including labels and markings - Areas used to store regulated
medical waste must be accessible only to authorized personnel. - Vermin and
insects must be controlled. - All floor drains in the storage area must
discharge directly to an approved sanitary sewer (sewer or septic system). -
Ventilation must be provided. - A plan must be maintained at the facility to
ensure proper management of regulated medical waste. (.1206)
Storage of Regulated Medical Waste That Will Be Shipped Off Site for Treatment
A waste generator who
stores regulated medical waste that will be shipped off site for treatment must
store the waste in a package suitable for transportation. (.1204(a))
Packaging Requirements for Regulated Medical Waste Which Will Be Treated On
Site
The packaging
requirements in section .1204 only apply to regulated medical waste that is
being shipped off site for treatment. There is no packaging requirement for
regulated medical waste treated on site.
Storage Requirements for Medical Waste Which Is Not Classified as Regulated
Medical Waste
If none of the medical
waste being stored is regulated medical waste, the waste is subject to the
storage requirements of general solid waste. As with regulated medical waste,
non-regulated medical waste must be stored in a non-putrescent state, and
vermin and insects must be controlled.
Manifesting Requirements
North Carolina does not
have a manifesting requirement and does not require "cradle to grave"
tracking of medical waste.
Generator Responsibilities for Proper Disposal by Commercial Facilities
Generators are
responsible for ensuring that waste is disposed of properly. If there is any
question about a commercial treatment facility's permit, please contact the
Solid Waste Section. (15A NCAC 13B .0106)
Self-Transporting Regulated Medical Waste
The requirements in
Section .1205 apply to any person transporting waste off site for treatment.
There are no manifest or registration requirements. Haulers must comply with
any relevant Department of Transportation regulations.
Shipping Non-Regulated Medical Waste Off-Site for Treatment
Only regulated medical
waste is subject to the packaging, labeling and transportation requirements.
Other waste may be handled as general solid waste so long as it meets
applicable packaging requirements for sharps and containers of blood with 20 cc
or less.
Packaging and Labeling Requirements for Regulated Medical Waste That Will Be
Treated On Site
Regulated medical waste
that will be treated on site is not subject to the packaging and labeling
requirements. Generators still must comply with any relevant OSHA requirements
for packaging and labeling for workplace safety.
Treatment Facilities for Regulated Medical
Waste
Regulated Medical Waste
may be treated on site or at a facility that is an integrated part of the
generating facility (See .1201(3) for definition of integrated). Otherwise, it
must be sent to a medical waste treatment facility permitted by the Solid Waste
Section (See list on page 29). Many generators choose to ship and incinerate
non-regulated medical waste such as gloves, bloody bandages, dressings, and
tubing. Generators who incur this expense should be reminded that this is not
required by OSHA or any other state agency. Such waste may be landfilled
untreated even though it may be designated as regulated waste by OSHA.
(.1203(a))
Permitting of Medical Waste Treatment Facilities
Solid waste permits are
not required for facilities that treat only waste generated within the
facility. Permits are required for facilities that treat medical waste
generated off site and not within an integrated medical facility.
Disposal of Large Volumes of Blood and Body Fluids
Incineration or
sanitary sewage are acceptable treatments for blood and body fluids in
individual containers in volumes greater than 20 ml. If neither of these
options is available on site, a vendor must be obtained to treat the material.
Urine and Feces
Disposal of Items Such
as Bloody Gauze, Used Gloves, Tubing, and Dressings. These materials are not
regulated medical waste and, therefore, do not have any specific treatment
requirement. They may be disposed of as general solid waste. Note that some of
these items may be subject to packaging and labeling requirements by OSHA. The
Solid Waste Section does not recommend removing these labels at the point of
disposal.
Arranging for Incineration of Regulated Medical Waste by a Neighboring Hospital
Any facility treating
waste that is generated off site and outside of an integrated medical facility
must obtain a permit from the Solid Waste Section. All packaging, labeling,
transportation, storage, and treatment requirements apply.
The "50 Pound per Month" Record-Keeping Exemption
This exemption, in
Section .1204(b), exempts generators from the record-keeping requirement if
they ship less than 50 pounds per month of regulated medical waste.
Rejection of Properly Packaged Sharps or Treated Regulated Medical Waste at the
Local Municipal Landfill
Landfill operators have
the right to reject any waste for disposal in the landfill, even if state
regulations allow landfill disposal of such wastes.
Managing Medical Waste After It Has Been Treated
Treated medical waste
is subject to the same requirements as general solid waste. (.1203(c))
Disposal of Regulated Medical Waste with
Casketed Remains
Caskets containing
human remains were intended for interment or cremation, so they will not be
regulated under the rules. Remains intended for disposal may not be placed in a
casket as a means of disposal; such wastes are considered pathological wastes and
are subject to all applicable requirements.
Special Cases Where Religious Practices Require That a Body Be Interred with
Removed Organs as Well as Tubing and Sharps
These practices are
acceptable. The rules are not intended to interfere with the religious
preferences of any individual.
Sharps Used During the Course of Preparing a Body for Interment, Including
Scalpels, Needles and Other Instruments
These sharps are
medical waste and therefore subject to all applicable requirements in the
medical waste rules. (.1202(b))
Using Crematoriums for Incineration of Regulated Medical Waste
Crematoriums do not
meet the incineration requirements of the medical waste management rules. All
medical waste incinerators must meet the requirements. Cremation is an acceptable
form of disposal for fetal remains. (.1207(3))
Contracts with Commercial Medical Waste Treatment Companies to Treat Funeral
Home Waste
With the exception of
blood, which can be treated by sanitary sewer, most funeral homes do not
generate regulated medical waste. Non-regulated medical waste may require
special packaging (see .1202), but it does not require incineration.
SPECIAL ARRANGEMENTS FOR TREATING WASTE GENERATED
OFF-SITE - EXAMPLES
Facility "G" (the generator)
sends its regulated medical waste to facility "T" for treatment. What
packaging, labeling, record-keeping, transportation and treatment requirements
apply?
To answer this
question, two determinations must be made:
1. whether sites G and T are an "integrated medical facility" (See
definition below); and
2. whether G is "on-site" or "off-site" relative to
facility T. That is, if you are at one facility, is the other on-site? (See
definition below).
After determining whether a facility is an integrated medical facility and/or
on or off- site, the table below may be used to find out what requirements
apply. See examples.
|
|
Integrated Facility |
Non-Integrated Facility |
|
On-site |
Exempt
from packaging,labeling,storage, and record-keeping requirements. |
Exempt
from packaging and labeling requirements. Subject to storage and
record-keeping requirements. Treatment facility must hold a permit issued by
the Solid Waste Section |
|
Off-site |
Exempt
from recordkeeping and storage requirements. Subject to packaging, labeling
and transportation requirements. |
Subject
to all packaging, labeling, storage, record-keeping and transportation
requirements. Treatment facility must hold a permit issued by the Solid Waste
Section. |
Definitions:
Integrated medical facility means one or more health service facilities as
defined in NCGS 131E-176(9b) (see definition on page 21) that are:
(a) located in a single county or two contiguous counties;
(b) affiliated with a university medical school or that are under common ownership and control; and
(c) serve a single service area. (.1201(3))
"Health service facility" means a
hospital; psychiatric facility; rehabilitation facility; long term health care
facility; kidney disease treatment center, including freestanding hemodialysis
units; intermediate care facility for the mentally retarded; home health
agency; chemical dependency treatment facility; and ambulatory surgical
treatment facility. (131E-176(9b))
Funeral homes, veterinary hospitals, dental and research labs are not
integrated facilities.
On-site means the same or geographically contiguous property which may be
divided by public or private right-of-way. (.1201(7))
Off-site means any site which is not on-site. (.1201(6))
The following examples will help to determine what requirements apply under a
variety of situations.
Example A
Facility G is a hospital sending its pathological and microbiological waste
across town to facility T, also a hospital, for treatment. G and T are under
common ownership and in the same county but not on a geographically contiguous
piece of property. What requirements apply?
Step 1. Are G and T an integrated medical facility?
Yes. G and T meet the three criteria for being an integrated facility - they
areunder common ownership, serve a single service area and are located in a
single county.
Step 2. Are T and G on-site? (Or, if you are at facility T, is G on-site?)
No. The facilities are not on-site because they are not on a geographically contiguous
piece of property.
Answer: The table shows facilities that are integrated and off-site are
exempt from the record-keeping and storage requirements, but must comply with
packaging, labeling and transportation requirements.
Example B
Facility G, a veterinary hospital, is sending animal carcasses that are
infected with rabies to facility T, a hospital, for treatment. The facilities
are not under common ownership and are on separately owned pieces of property
that are geographically contiguous. What requirements apply?
Step 1. Are the facilities an integrated medical facility?
No. The facilities are not under common ownership. Furthermore, veterinary
facilities are not included in the definition of a health care facility.
Step 2. Are the facilities on-site?
Yes. The facilities are on geographically contiguous property.
Answer: The facilities are non-integrated and on-site. The table shows
they are exempt from the packaging and labeling requirements, but are not
exempt from the storage and record-keeping requirement. Additionally, the
treatment facility must hold a permit issued by the Solid Waste Section.
Example C
A university hospital, T, treats waste from a hospital affiliated lab, G,
across campus. The campus is a geographically contiguous piece of property.
What requirements apply?
Step 1.Are they an integrated medical facility?
Yes. The facilities are located in the same county, affiliated with a
university medical school and serve the same area.
Step 2.Are the facilities on-site?
Yes. They are on a geographically contiguous piece of property.
Answer: The facilities are on-site and integrated. The table shows that
they are exempt from packaging, labeling, storage and record-keeping
requirements.
Example D
A pathology laboratory, G, sends regulated medical waste to a local hospital,
T, across town. The pathology lab and the hospital are not under common
ownership or on geographically contiguous property.
Step 1. Are the facilities integrated?
No. They are not under common ownership.
Step 2.Are the facilities on-site?
No. They are not on the same or geographically contiguous property.
Answer: The facilities are off-site and non-integrated. The table shows
that they are each subject to the packaging, labeling, storage, record keeping
and transportation requirements. The treatment facility would need a permit
issued by the Solid Waste Section.
INTERFACE WITH OSHA REGULATIONS Impact of the OSHA
Bloodborne Pathogen Standards on Medical Waste Disposal Requirements
The new OSHA standards
do not address disposal methods, and no changes have been made in state medical
waste treatment and disposal rules. OSHA Instruction CPL 2-2.44D states
"that while OSHA specifies certain features of the regulated waste
containers, including appropriate tagging, the ultimate disposal method
(landfilling, incineration, and so forth) for medical waste falls under the
purview of the EPA and possibly State and local regulations.
Comparison of the Definition of Regulated Medical Waste with the OSHA
Definition of Regulated Waste
There are substantial
differences in the two definitions. For example, the OSHA definition of
regulated waste may include waste such as bloody gauze, blood-saturated
dressings, used gloves, or tubing. These items are not included in the state
definition of regulated medical waste and are exempt from treatment
requirements. It is essential the generator understand both definitions.
Generators who apply the OSHA definition of regulated waste to designate waste
for treatment by incineration may unintentionally incur additional expense. The
OSHA definition of regulated waste is not intended to designate waste that must
be incinerated or otherwise treated before landfilling.
Disposal of Blood and Body Fluids into the Sanitary Sewer
The sanitary sewage
treatment system is designed for disposal of body fluids. OSHA regulations do
not address disposal and do not prohibit such disposal. Workers disposing blood
are of course subject to OSHA requirements, such as wearing protective clothing.
Different Labeling Requirements
Generators must be
familiar with both sets of requirements. OSHA may require a red bag or
biohazard-labeled bag for some waste that can be safely disposed in the
landfill without treatment. That could include properly containerized sharps,
used gloves, bloody gauze and dressings, and properly containerized blood and
body fluids in volumes of 20 mL or less.
State waste disposal regulations require the words "INFECTIOUS WASTE"
or "MEDICAL WASTE" on packages of regulated medical waste that are
taken off site for treatment and disposal. State medical waste disposal
regulations no longer require the use of red bags since the red dyes may
contribute heavy metals, such as lead and cadmium, to incinerator ash disposed
in landfills. State solid waste goals include reducing the toxicity of
landfilled waste. Users of red bags should check with their vendors to ensure
they are using bags that do not create toxic residues after incineration.
Disposal of Red Bags That Contain Only Medical Waste Not Classified as
Regulated Medical Waste by the State Medical Waste Management Definition
Bags that contain only
non-regulated medical waste in accordance with state rules and are labeled as
biohazardous in the workplace, are "over-labeled" for disposal
purposes. Such labels were previously reserved to designate waste that was
banned from the landfill and must be treated. Red bags and biohazard-labeled
bags that contain only non-regulated medical waste may be disposed with general
solid waste, provided no local rules prohibit it.
The Solid Waste Section has alerted North Carolina landfills to expect
increased disposal of non-regulated medical waste in red bags or biohazard-labeled
bags as the OSHA rules are implemented. In some counties, landfill operators
initially may not accept such bags, even though they had previously accepted
the same waste in plain, unlabeled bags.
In most cases, this can be worked out through local discussions and better
communications with the landfill. Landfill operation is regulated by the Solid
Waste Section, and local waste management specialists are available to provide
assistance, guidance, and education for landfill operators.
As described in paragraphs (g)(1)(i)(B),(C),(D), and (E) of the OSHA standards,
the OSHA labeling requirements can be satisfied by the use of either red bags
or bags with a biohazard label. Facilities sending waste to the landfill may
find plain bags with the appropriate biohazard label an easy solution.
Risks to Waste Industry Workers
Waste transport and
disposal is mechanized, and waste handlers are trained to safely deal with all
types of waste that contain human pathogens. To keep things in perspective, it is
important to realize that household garbage has on average 100 times more
pathogenic microorganisms than general medical waste.
Problems with Using the OSHA Definition of
Regulated Waste to Designate Waste That Must Be Treated and Cannot Be Disposed
at the Landfill
The OSHA definition
designates waste that poses a threat in the workplace, and does not designate
waste that should be incinerated or treated by other means. Applying this
definition to disposal would constitute imposing treatment requirements to
additional categories of medical waste. Requiring treatment of very broad
categories of medical waste may increase waste management costs substantially,
while providing no benefit for the environment or public health.
Adopting Uniform Definitions for the
Department of Labor and Department of Environment and Natural Resources
The rules do not
conflict, but they address two entirely different concerns. Federal OSHA rules
address waste management in the workplace to ensure worker safety; state solid
waste management rules ensure storage, shipping, and disposal practices that
protect the environment and public health. Categories of waste that present
special infectious hazards in the workplace do not necessarily present the same
hazards to the environment or public health once in the disposal process.
means any solid waste
which is generated in the diagnosis, treatment, or immunization of human beings
or animals, in research pertaining thereto, or in the production or testing of
biologicals, but does not include any hazardous waste identified or listed
pursuant to this Article, radioactive waste, household waste as defined in 40
Code of Federal Regulations § 261.4(b)(1) in effect on 1 July 1989, or those
substances excluded from the definition of solid waste in this section. (NCGS
130A-290(18))
Health service facility
means a hospital;
psychiatric facility; rehabilitation facility; long term care facility; kidney
disease treatment center, including freestanding hemodialysis units;
intermediate care facility for the mentally retarded; home health agency;
chemical dependency treatment facility; and ambulatory surgical facility. (NCGS
131E-176(9b))
Treatment
means any method,
technique or process, including neutralization, designed to change the
physical, chemical or biological character or composition of any hazardous
waste so as to neutralize such waste or so as to render such waste
nonhazardous, safer for transport, amenable for recovery, amenable for storage
or reduced in volume. Treatment includes any activity or processing designed to
change the physical form or chemical composition of hazardous waste so as to
render it nonhazardous.(NCGS 130A-290(a)(42))