Standards for Bloodborne Pathogens
In 1991, the Occupational Safety and Health Administration
(OSHA) promulgated the Occupational
Exposure to Bloodborne Pathogens Standard . This standard is designed
to protect approximately 5.6 million workers in the healthcare and related
occupations from the risk of exposure to bloodborne pathogens, such as the
Human Immunodeficiency Virus (HIV) and the Hepatitis B Virus (HBV).
The Bloodborne Pathogens Standard has numerous requirements,
including the development of an Exposure Control Plan. The Standard also
includes rules specific to certain types of wastes generated at healthcare
facilities, termed “regulated waste.” Regulated waste includes
blood and items contaminated with blood or other potentially infectious materials
(OPIM). This section of the HERC Center contains a summary of OSHA Bloodborne
Pathogens Standards relating to regulated waste.
- What is an Exposure Control Plan
- What does OSHA mean by the term "regulated
- Management of Sharps
- How should sharps containers be handled?
- Where should sharps containers be located?
- What type of container should
be purchased to dispose of sharps?
- Disposal of Regulated Waste
- How do I dispose of regulated waste?
- Communication of Hazard to
- When are labels required?
- What are the required colors for the labels?
- Can there be substitutes for the labels?
- What are the exceptions to the labeling requirement?
- Does OSHA accept Department of Transportation's
(DOT) labels for waste and specimens which will be shipped or transported?
- Which employees must be trained?
- Should part-time and temporary employees be trained?
- Who has the responsibility for training workers
employed by agencies which provide personnel (e.g., nurses) to other
- What are the qualifications that a person must possess
in order to conduct employee training regarding bloodborne pathogens?
- Where could information be obtained for conducting
training on the Bloodborne Pathogens Standard?
- Who are some examples of persons who could conduct
training on the bloodborne standard?
What is an Exposure Control Plan?
The exposure control plan is the employer's written program that outlines
the protective measures an employer will take to eliminate or minimize employee
exposure to blood and OPIM.
The exposure control plan must contain at a minimum:
- an exposure determination which identifies job classifications
and, in some cases, tasks and procedures where there is occupational exposure
to blood and OPIM;
- procedures for evaluating the circumstances surrounding
an exposure incident; and
- a schedule of how and when other provisions of the standard
will be implemented, including methods of compliance, communication of hazards
to employees, and recordkeeping.
What does OSHA mean by the term "regulated waste"?
The Bloodborne Pathogens Standard uses the term, "regulated waste," to
refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious
- items contaminated with blood or OPIM and which would
release these substances in a liquid or semi-liquid state if compressed;
- items that are caked with dried blood or OPIM and are
capable of releasing these materials during handling;
- contaminated sharps; and
- pathological and microbiological wastes containing blood
It is the employer's responsibility to determine the existence
of regulated waste. This determination should not based on actual volume
of blood, but rather on the potential to release blood, (e.g., when compacted
in the waste container). If an OSHA inspector determines that sufficient
evidence of regulated waste exists, either through observation, (e.g., a pool
of liquid in the bottom of a container, dried blood flaking off during handling),
or based on employee interviews, citations may be issued.
OSHA has provided some additional guidance for the determination
of regulated waste. OSHA stated that bandages which are not saturated
to the point of releasing blood or OPIM if compressed would not be considered
as regulated waste. Similarly, discarded feminine hygiene products do
not normally meet the criteria for regulated waste as defined by the standard. Beyond
these guidelines, it is the employer's responsibility to determine the existence
of regulated waste.
Management of Sharps
How should sharps containers be handled?
Each sharps container must either be labeled with the universal biohazard
symbol and the word "biohazard" or be color-coded red. Sharps
containers must be maintained upright throughout use, replaced routinely, and
not be allowed to overfill. Also, the containers must be:
- Closed immediately prior to removal or replacement to
prevent spillage or protrusion of contents during handling, storage, transport,
- Placed in a secondary container if leakage is possible.
The second container must be:
- Constructed to contain all contents and prevent
leakage during handling, storage, transport, or shipping; and
- Labeled or color-coded according to the standard.
- Reusable containers must not be opened, emptied, or cleaned
manually or in any other manner that would expose employees to the risk of
- Upon closure, duct tape may be used to secure the lid
of a sharps container, as long as the tape does not serve as the lid itself.
Where should sharps containers be located?
Sharps containers must be easily accessible to employees and located
as close as feasible to the immediate area where sharps are used (e.g., patient
In areas, such as correctional facilities and psychiatric
units, there may be difficulty placing sharps containers in the immediate use
area. If a mobile cart is used in these areas, an alternative would be
to lock the sharps container in the cart.
What type of container should be purchased to dispose
Sharps containers are made from a variety of products from cardboard
to plastic. As long as they meet the definition of a sharps container
(i.e., containers must be closable, puncture resistant, leak proof on sides
and bottom, and labeled or color-coded), OSHA would consider them to be of
an acceptable composition.
For more information on sharps containers and proper placement, see Selecting, Evaluating and Using Sharps Containers, a guidance document issued by the National Institute for Occupational Safety and Health (NIOSH) (Figure 1 on page 12 of the document shows measurements for proper placement).
How do I dispose of regulated waste?
Disposal of all regulated waste must be in accordance with applicable
state regulations. These rules are typically published by state environmental
agencies and/or state departments of health (Go
to HERC Regulated Medical Waste Locator ).
In addition to state rules for disposing of regulated waste,
there are basic OSHA requirements that protect workers. The OSHA rules
state that regulated waste must be placed in containers which are:
- Constructed to contain all contents and prevent leakage
of fluids during handling, storage, transport or shipping;
- Labeled or color-coded in accordance with the standard;
- Closed prior to removal to prevent spillage or protrusion
of contents during handling, storage, transport, or shipping.
- If outside contamination of the regulated waste container
occurs, it must be placed in a second container meeting the above standards.
OSHA has no specific requirement for hospitals or other healthcare
facilities to treat (e.g., autoclave) waste before disposal. Such rules
are usually published by state agencies ( Go
to HERC Regulated Medical Waste Locator ).
Communication of Hazard to Employees
When are labels required?
A warning label that includes the universal biohazard symbol, followed
by the term "biohazard," must be included on bags/containers of regulated
waste , on bags/containers of contaminated laundry, on refrigerators and freezers
that are used to store blood or OPIM, and on bags/containers used to store,
dispose of, transport, or ship blood or OPIM (e.g., specimen containers). In
addition, contaminated equipment which is to be serviced or shipped must have
a readily observable label attached which contains the biohazard symbol and
the word "biohazard" along with a statement relating which portions
of the equipment remain contaminated
What are the required colors for the labels?
The background must be fluorescent orange or orange-red or predominantly
so, with symbols and lettering in a contrasting color. The label must be either
an integral part of the container or affixed as close as feasible to the container
by a string, wire, adhesive, or other method to prevent its loss or unintentional
Can there be substitutes for the labels?
Yes. Red bags or red containers may be substituted for the biohazard
What are the exceptions to the labeling requirement?
Labeling is not required for:
- Regulated waste that has been decontaminated.
- Containers of blood, blood components, and blood products
bearing an FDA required label that have been released for transfusion or
other clinical uses.
- Individual containers of blood or OPIM that are placed
in secondary labeled containers during storage, transport, shipment, or disposal.
- Specimen containers, if the facility uses Universal Precautions
when handling all specimens, the containers are recognizable as containing
specimens, and the containers remain within the facility. *(see note below
concerning specimen bags)
- Laundry bags or containers, containing contaminated laundry,
may be marked with an alternative label or color-coded provided the facility
uses Universal Precautions for handling all soiled laundry and the alternative
marking permits all employees to recognize the containers as requiring compliance
with Universal Precautions. If contaminated laundry is sent off-site for
cleaning to a facility which does not use Universal Precautions in the handling
of all soiled laundry, it must be placed in a bag or container which is red
in color or labeled with the biohazard label described above.
*A note concerning Specimen Bags: Some healthcare
facilities use plastic bags to transport specimen containers from patient care
areas to in-house laboratories. The healthcare facilities label the plastic
bag "biohazard" and dispose of the plastic bag as infectious waste.
If not contaminated, the plastic transport bags are not considered
infectious waste and may be disposed of as solid waste. However, if the bags
are labeled "biohazard," healthcare facilities run the risk that
the solid waste hauler might refuse to transport the waste because of the belief
that the bags are infectious.
Biohazard labeled plastic bags used as secondary containment
for internal transport of specimens is not required by OSHA. The labeling exemption,
listed in 29
CFR 1910.1030 (d)(2)(xii)(A) of the Occupational Exposure to Bloodborne
Pathogens, applies to facilities that handle all specimens with Universal Precautions,
provided the containers are recognizable as containing specimens. The exemption
applies only while these specimens remain within the facility. If the specimens
leave the facility, a label or red color-coding is required. In addition, secondary
containers or bags are only required if the primary container is contaminated
on the outside.
Does OSHA accept Department of Transportation's (DOT)
labels for waste and specimens which will be shipped or transported?
The labeling requirements do not preempt either the U.S. Postal Service
labeling requirements (39 CFR Part III) or the Department of Transportation's
Hazardous Materials Regulations (49 CFR Parts 171-181).
DOT labeling is required on some transport containers (i.e.,
those containing "known infectious substances"). It is not required
on all containers for which 29 CFR 1910.1030 requires the biohazard label.
Where there is an overlap between the OSHA-mandated label and the DOT-required
label, the DOT label will be considered acceptable on the outside of the transport
container provided the OSHA-mandated label appears on any internal containers
which may be present. Containers serving as collection receptacles within a
facility must bear the OSHA label since these are not covered by the DOT requirements.
Which employees must be trained?
All employees with occupational exposure must receive initial and
Should part-time and temporary employees be trained?
Part-time and temporary employees are covered and are also to be trained
on company time.
Who has the responsibility for training workers employed
by agencies which provide personnel (e.g., nurses) to other employers?
OSHA considers personnel providers, who send their own employees to
work at other facilities, to be employers whose employees may be exposed to
hazards. Since personnel providers maintain a continuing relationship with
their employees, but another employer (your client) creates and controls the
hazard, there is a shared responsibility for assuring that your employees are
protected from workplace hazards. The client employer has the primary responsibility
for such protection, but the "lessor employer" likewise has a responsibility
under the Occupational Safety and Health Act.
In the context of OSHA's standard on Bloodborne Pathogens,
the personnel provider would be required to provide the general training outlined
in the standard, the client employer would be responsible for providing site-specific
The contract between the personnel provider and the client should clearly describe
the training responsibilities of both parties in order to ensure that all training
requirements of the standard are met.
What are the qualifications that a person must possess
in order to conduct employee training regarding bloodborne pathogens?
The person conducting the training is required to be knowledgeable
in the subject matter covered by the elements in the training program and be
familiar with how the course topics apply to the workplace that the training
will address. The trainer must demonstrate expertise in the area of occupational
hazards of bloodborne pathogens.
Where could information be obtained for conducting training on the
Bloodborne Pathogens Standard?
OSHA's Office of Information and Consumer Affairs (OICA) has developed
brochures, factsheets, and a videotape on the standard. Single copies of the
brochure and factsheets can be obtained by writing OSHA Publications, 200 Constitution
Avenue, NW, Room N3101, Washington, DC 20210 or by calling (202) 219-8148 the
videotape is available through the National Audio Visual Center, and the number
is (800)-553-6847. All information available through OICA should be used as
a supplement to the employer's training program. Other sources of information
include local Area and Regional OSHA Offices. In addition, each Regional Office
has a Bloodborne Pathogens Coordinator who answers compliance and related questions
on the standard.
Who are some examples of persons who could conduct
training on the bloodborne standard?
Examples of health care professionals include infection control practitioners,
nurse practitioners, and registered nurses. Non-health care professionals include
industrial hygienists, epidemiologists or professional trainers, provided that
they can demonstrate evidence of specialized training in the area of bloodborne