[Code of Federal Regulations]
[Title 29, Volume 6, Parts 1910.1000 to end]
[Revised as of July 1, 1998]
From the U.S. Government Printing Office via GPO Access
CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (Continued)
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS (Continued)--Table of Contents
Subpart Z--Toxic and Hazardous Substances
Sec. 1910.1030 Bloodborne pathogens.
(a) Scope and Application. This section applies to all occupational
exposure to blood or other potentially infectious materials as defined
by paragraph (b) of this section.
(b) Definitions. For purposes of this section, the following shall
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, or designated representative.
Blood means human blood, human blood components, and products made
from human blood.
Bloodborne Pathogens means pathogenic microorganisms that are
present in human blood and can cause disease in humans. These pathogens
include, but are not limited to, hepatitis B virus (HBV) and human
immunodeficiency virus (HIV).
Clinical Laboratory means a workplace where diagnostic or other
screening procedures are performed on blood or other potentially
Contaminated means the presence or the reasonably anticipated
presence of blood or other potentially infectious materials on an item
Contaminated Laundry means laundry which has been soiled with blood
or other potentially infectious materials or may contain sharps.
Contaminated Sharps means any contaminated object that can penetrate
the skin including, but not limited to,
needles, scalpels, broken glass, broken capillary tubes, and exposed
ends of dental wires.
Decontamination means the use of physical or chemical means to
remove, inactivate, or destroy bloodborne pathogens on a surface or item
to the point where they are no longer capable of transmitting infectious
particles and the surface or item is rendered safe for handling, use, or
Director means the Director of the National Institute for
Occupational Safety and Health, U.S. Department of Health and Human
Services, or designated representative.
Engineering Controls means controls (e.g., sharps disposal
containers, self-sheathing needles) that isolate or remove the
bloodborne pathogens hazard from the workplace.
Exposure Incident means a specific eye, mouth, other mucous
membrane, non-intact skin, or parenteral contact with blood or other
potentially infectious materials that results from the performance of an
Handwashing Facilities means a facility providing an adequate supply
of running potable water, soap and single use towels or hot air drying
Licensed Healthcare Professional is a person whose legally permitted
scope of practice allows him or her to independently perform the
activities required by paragraph (f) Hepatitis B Vaccination and Post-
exposure Evaluation and Follow-up.
HBV means hepatitis B virus.
HIV means human immunodeficiency virus.
Occupational Exposure means reasonably anticipated skin, eye, mucous
membrane, or parenteral contact with blood or other potentially
infectious materials that may result from the performance of an
Other Potentially Infectious Materials means
(1) The following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid,
peritoneal fluid, amniotic fluid, saliva in dental procedures, any body
fluid that is visibly contaminated with blood, and all body fluids in
situations where it is difficult or impossible to differentiate between
(2) Any unfixed tissue or organ (other than intact skin) from a
human (living or dead); and
(3) HIV-containing cell or tissue cultures, organ cultures, and HIV-
or HBV-containing culture medium or other solutions; and blood, organs,
or other tissues from experimental animals infected with HIV or HBV.
Parenteral means piercing mucous membranes or the skin barrier
through such events as needlesticks, human bites, cuts, and abrasions.
Personal Protective Equipment is specialized clothing or equipment
worn by an employee for protection against a hazard. General work
clothes (e.g., uniforms, pants, shirts or blouses) not intended to
function as protection against a hazard are not considered to be
personal protective equipment.
Production Facility means a facility engaged in industrial-scale,
large-volume or high concentration production of HIV or HBV.
Regulated Waste means liquid or semi-liquid blood or other
potentially infectious materials; contaminated items that would release
blood or other potentially infectious materials in a liquid or semi-
liquid state if compressed; items that are caked with dried blood or
other potentially infectious materials and are capable of releasing
these materials during handling; contaminated sharps; and pathological
and microbiological wastes containing blood or other potentially
Research Laboratory means a laboratory producing or using research-
laboratory-scale amounts of HIV or HBV. Research laboratories may
produce high concentrations of HIV or HBV but not in the volume found in
Source Individual means any individual, living or dead, whose blood
or other potentially infectious materials may be a source of
occupational exposure to the employee. Examples include, but are not
limited to, hospital and clinic patients; clients in institutions for
the developmentally disabled; trauma victims; clients of drug and
alcohol treatment facilities; residents of hospices and nursing homes;
human remains; and individuals who donate or sell blood or blood
Sterilize means the use of a physical or chemical procedure to
destroy all microbial life including highly resistant bacterial
Universal Precautions is an approach to infection control. According
to the concept of Universal Precautions, all human blood and certain
human body fluids are treated as if known to be infectious for HIV, HBV,
and other bloodborne pathogens.
Work Practice Controls means controls that reduce the likelihood of
exposure by altering the manner in which a task is performed (e.g.,
prohibiting recapping of needles by a two-handed technique).
(c) Exposure control--(1) Exposure Control Plan. (i) Each employer
having an employee(s) with occupational exposure as defined by paragraph
(b) of this section shall establish a written Exposure Control Plan
designed to eliminate or minimize employee exposure.
(ii) The Exposure Control Plan shall contain at least the following
(A) The exposure determination required by paragraph(c)(2),
(B) The schedule and method of implementation for paragraphs (d)
Methods of Compliance, (e) HIV and HBV Research Laboratories and
Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure
Evaluation and Follow-up, (g) Communication of Hazards to Employees, and
(h) Recordkeeping, of this standard, and
(C) The procedure for the evaluation of circumstances surrounding
exposure incidents as required by paragraph (f)(3)(i) of this standard.
(iii) Each employer shall ensure that a copy of the Exposure Control
Plan is accessible to employees in accordance with 29 CFR 1910.20(e).
(iv) The Exposure Control Plan shall be reviewed and updated at
least annually and whenever necessary to reflect new or modified tasks
and procedures which affect occupational exposure and to reflect new or
revised employee positions with occupational exposure.
(v) The Exposure Control Plan shall be made available to the
Assistant Secretary and the Director upon request for examination and
(2) Exposure determination. (i) Each employer who has an employee(s)
with occupational exposure as defined by paragraph (b) of this section
shall prepare an exposure determination. This exposure determination
shall contain the following:
(A) A list of all job classifications in which all employees in
those job classifications have occupational exposure;
(B) A list of job classifications in which some employees have
occupational exposure, and
(C) A list of all tasks and procedures or groups of closely related
task and procedures in which occupational exposure occurs and that are
performed by employees in job classifications listed in accordance with
the provisions of paragraph (c)(2)(i)(B) of this standard.
(ii) This exposure determination shall be made without regard to the
use of personal protective equipment.
(d) Methods of compliance--(1) General. Universal precautions shall
be observed to prevent contact with blood or other potentially
infectious materials. Under circumstances in which differentiation
between body fluid types is difficult or impossible, all body fluids
shall be considered potentially infectious materials.
(2) Engineering and work practice controls. (i) Engineering and work
practice controls shall be used to eliminate or minimize employee
exposure. Where occupational exposure remains after institution of these
controls, personal protective equipment shall also be used.
(ii) Engineering controls shall be examined and maintained or
replaced on a regular schedule to ensure their effectiveness.
(iii) Employers shall provide handwashing facilities which are
readily accessible to employees.
(iv) When provision of handwashing facilities is not feasible, the
employer shall provide either an appropriate antiseptic hand cleanser in
conjunction with clean cloth/paper towels or antiseptic towelettes. When
antiseptic hand cleansers or towelettes are used, hands shall be washed
with soap and running water as soon as feasible.
(v) Employers shall ensure that employees wash their hands
immediately or as soon as feasible after removal of gloves or other
personal protective equipment.
(vi) Employers shall ensure that employees wash hands and any other
skin with soap and water, or flush mucous membranes with water
immediately or as soon as feasible following contact of such body areas
with blood or other potentially infectious materials.
(vii) Contaminated needles and other contaminated sharps shall not
be bent, recapped, or removed except as noted in paragraphs
(d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of
contaminated needles is prohibited.
(A) Contaminated needles and other contaminated sharps shall not be
bent, recapped or removed unless the employer can demonstrate that no
alternative is feasible or that such action is required by a specific
medical or dental procedure.
(B) Such bending, recapping or needle removal must be accomplished
through the use of a mechanical device or a one-handed technique.
(viii) Immediately or as soon as possible after use, contaminated
reusable sharps shall be placed in appropriate containers until properly
reprocessed. These containers shall be:
(A) Puncture resistant;
(B) Labeled or color-coded in accordance with this standard;
(C) Leakproof on the sides and bottom; and
(D) In accordance with the requirements set forth in paragraph
(d)(4)(ii)(E) for reusable sharps.
(ix) Eating, drinking, smoking, applying cosmetics or lip balm, and
handling contact lenses are prohibited in work areas where there is a
reasonable likelihood of occupational exposure.
(x) Food and drink shall not be kept in refrigerators, freezers,
shelves, cabinets or on countertops or benchtops where blood or other
potentially infectious materials are present.
(xi) All procedures involving blood or other potentially infectious
materials shall be performed in such a manner as to minimize splashing,
spraying, spattering, and generation of droplets of these substances.
(xii) Mouth pipetting/suctioning of blood or other potentially
infectious materials is prohibited.
(xiii) Specimens of blood or other potentially infectious materials
shall be placed in a container which prevents leakage during collection,
handling, processing, storage, transport, or shipping.
(A) The container for storage, transport, or shipping shall be
labeled or color-coded according to paragraph (g)(1)(i) and closed prior
to being stored, transported, or shipped. When a facility utilizes
Universal Precautions in the handling of all specimens, the labeling/
color-coding of specimens is not necessary provided containers are
recognizable as containing specimens. This exemption only applies while
such specimens/containers remain within the facility. Labeling or color-
coding in accordance with paragraph (g)(1)(i) is required when such
specimens/containers leave the facility.
(B) If outside contamination of the primary container occurs, the
primary container shall be placed within a second container which
prevents leakage during handling, processing, storage, transport, or
shipping and is labeled or color-coded according to the requirements of
(C) If the specimen could puncture the primary container, the
primary container shall be placed within a secondary container which is
puncture-resistant in addition to the above characteristics.
(xiv) Equipment which may become contaminated with blood or other
potentially infectious materials shall be examined prior to servicing or
shipping and shall be decontaminated as necessary, unless the employer
can demonstrate that decontamination of such equipment or portions of
such equipment is not feasible.
(A) A readily observable label in accordance with paragraph
(g)(1)(i)(H) shall be attached to the equipment stating which portions
(B) The employer shall ensure that this information is conveyed to
all affected employees, the servicing representative, and/or the
manufacturer, as appropriate, prior to handling, servicing, or shipping
so that appropriate precautions will be taken.
(3) Personal protective equipment--(i) Provision. When there is
occupational exposure, the employer shall provide, at no cost to the
personal protective equipment such as, but not limited to, gloves,
gowns, laboratory coats, face shields or masks and eye protection, and
mouthpieces, resuscitation bags, pocket masks, or other ventilation
devices. Personal protective equipment will be considered
``appropriate'' only if it does not permit blood or other potentially
infectious materials to pass through to or reach the employee's work
clothes, street clothes, undergarments, skin, eyes, mouth, or other
mucous membranes under normal conditions of use and for the duration of
time which the protective equipment will be used.
(ii) Use. The employer shall ensure that the employee uses
appropriate personal protective equipment unless the employer shows that
the employee temporarily and briefly declined to use personal protective
equipment when, under rare and extraordinary circumstances, it was the
employee's professional judgment that in the specific instance its use
would have prevented the delivery of health care or public safety
services or would have posed an increased hazard to the safety of the
worker or co-worker. When the employee makes this judgement, the
circumstances shall be investigated and documented in order to determine
whether changes can be instituted to prevent such occurences in the
(iii) Accessibility. The employer shall ensure that appropriate
personal protective equipment in the appropriate sizes is readily
accessible at the worksite or is issued to employees. Hypoallergenic
gloves, glove liners, powderless gloves, or other similar alternatives
shall be readily accessible to those employees who are allergic to the
gloves normally provided.
(iv) Cleaning, Laundering, and Disposal. The employer shall clean,
launder, and dispose of personal protective equipment required by
paragraphs (d) and (e) of this standard, at no cost to the employee.
(v) Repair and Replacement. The employer shall repair or replace
personal protective equipment as needed to maintain its effectiveness,
at no cost to the employee.
(vi) If a garment(s) is penetrated by blood or other potentially
infectious materials, the garment(s) shall be removed immediately or as
soon as feasible.
(vii) All personal protective equipment shall be removed prior to
leaving the work area.
(viii) When personal protective equipment is removed it shall be
placed in an appropriately designated area or container for storage,
washing, decontamination or disposal.
(ix) Gloves. Gloves shall be worn when it can be reasonably
anticipated that the employee may have hand contact with blood, other
potentially infectious materials, mucous membranes, and non-intact skin;
when performing vascular access procedures except as specified in
paragraph (d)(3)(ix)(D); and when handling or touching contaminated
items or surfaces.
(A) Disposable (single use) gloves such as surgical or examination
gloves, shall be replaced as soon as practical when contaminated or as
soon as feasible if they are torn, punctured, or when their ability to
function as a barrier is compromised.
(B) Disposable (single use) gloves shall not be washed or
decontaminated for re-use.
(C) Utility gloves may be decontaminated for re-use if the integrity
of the glove is not compromised. However, they must be discarded if they
are cracked, peeling, torn, punctured, or exhibit other signs of
deterioration or when their ability to function as a barrier is
(D) If an employer in a volunteer blood donation center judges that
routine gloving for all phlebotomies is not necessary then the employer
(1) Periodically reevaluate this policy;
(2) Make gloves available to all employees who wish to use them for
(3) Not discourage the use of gloves for phlebotomy; and
(4) Require that gloves be used for phlebotomy in the following
(i) When the employee has cuts, scratches, or other breaks in his or
(ii) When the employee judges that hand contamination with blood may
occur, for example, when performing
phlebotomy on an uncooperative source individual; and
(iii) When the employee is receiving training in phlebotomy.
(x) Masks, Eye Protection, and Face Shields. Masks in combination
with eye protection devices, such as goggles or glasses with solid side
shields, or chin-length face shields, shall be worn whenever splashes,
spray, spatter, or droplets of blood or other potentially infectious
materials may be generated and eye, nose, or mouth contamination can be
(xi) Gowns, Aprons, and Other Protective Body Clothing. Appropriate
protective clothing such as, but not limited to, gowns, aprons, lab
coats, clinic jackets, or similar outer garments shall be worn in
occupational exposure situations. The type and characteristics will
depend upon the task and degree of exposure anticipated.
(xii) Surgical caps or hoods and/or shoe covers or boots shall be
worn in instances when gross contamination can reasonably be anticipated
(e.g., autopsies, orthopaedic surgery).
(4) Housekeeping--(i) General. Employers shall ensure that the
worksite is maintained in a clean and sanitary condition. The employer
shall determine and implement an appropriate written schedule for
cleaning and method of decontamination based upon the location within
the facility, type of surface to be cleaned, type of soil present, and
tasks or procedures being performed in the area.
(ii) All equipment and environmental and working surfaces shall be
cleaned and decontaminated after contact with blood or other potentially
(A) Contaminated work surfaces shall be decontaminated with an
appropriate disinfectant after completion of procedures; immediately or
as soon as feasible when surfaces are overtly contaminated or after any
spill of blood or other potentially infectious materials; and at the end
of the work shift if the surface may have become contaminated since the
(B) Protective coverings, such as plastic wrap, aluminum foil, or
imperviously-backed absorbent paper used to cover equipment and
environmental surfaces, shall be removed and replaced as soon as
feasible when they become overtly contaminated or at the end of the
workshift if they may have become contaminated during the shift.
(C) All bins, pails, cans, and similar receptacles intended for
reuse which have a reasonable likelihood for becoming contaminated with
blood or other potentially infectious materials shall be inspected and
decontaminated on a regularly scheduled basis and cleaned and
decontaminated immediately or as soon as feasible upon visible
(D) Broken glassware which may be contaminated shall not be picked
up directly with the hands. It shall be cleaned up using mechanical
means, such as a brush and dust pan, tongs, or forceps.
(E) Reusable sharps that are contaminated with blood or other
potentially infectious materials shall not be stored or processed in a
manner that requires employees to reach by hand into the containers
where these sharps have been placed.
(iii) Regulated Waste--(A) Contaminated Sharps Discarding and
Containment. (1) Contaminated sharps shall be discarded immediately or
as soon as feasible in containers that are:
(ii) Puncture resistant;
(iii) Leakproof on sides and bottom; and
(iv) Labeled or color-coded in accordance with paragraph (g)(1)(i)
of this standard.
(2) During use, containers for contaminated sharps shall be:
(i) Easily accessible to personnel and located as close as is
feasible to the immediate area where sharps are used or can be
reasonably anticipated to be found (e.g., laundries);
(ii) Maintained upright throughout use; and
(iii) Replaced routinely and not be allowed to overfill.
(3) When moving containers of contaminated sharps from the area of
use, the containers shall be:
(i) Closed immediately prior to removal or replacement to prevent
spillage or protrusion of contents during handling, storage, transport,
(ii) Placed in a secondary container if leakage is possible. The
second container shall be:
(B) Constructed to contain all contents and prevent leakage during
handling, storage, transport, or shipping; and
(C) Labeled or color-coded according to paragraph (g)(1)(i) of this
(4) Reusable containers shall not be opened, emptied, or cleaned
manually or in any other manner which would expose employees to the risk
of percutaneous injury.
(B) Other Regulated Waste Containment--(1) Regulated waste shall be
placed in containers which are:
(ii) Constructed to contain all contents and prevent leakage of
fluids during handling, storage, transport or shipping;
(iii) Labeled or color-coded in accordance with paragraph (g)(1)(i)
this standard; and
(iv) Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
(2) If outside contamination of the regulated waste container
occurs, it shall be placed in a second container. The second container
(ii) Constructed to contain all contents and prevent leakage of
fluids during handling, storage, transport or shipping;
(iii) Labeled or color-coded in accordance with paragraph (g)(1)(i)
of this standard; and
(iv) Closed prior to removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
(C) Disposal of all regulated waste shall be in accordance with
applicable regulations of the United States, States and Territories, and
political subdivisions of States and Territories.
(iv) Laundry. (A) Contaminated laundry shall be handled as little as
possible with a minimum of agitation. (1) Contaminated laundry shall be
bagged or containerized at the location where it was used and shall not
be sorted or rinsed in the location of use.
(2) Contaminated laundry shall be placed and transported in bags or
containers labeled or color-coded in accordance with paragraph (g)(1)(i)
of this standard. When a facility utilizes Universal Precautions in the
handling of all soiled laundry, alternative labeling or color-coding is
sufficient if it permits all employees to recognize the containers as
requiring compliance with Universal Precautions.
(3) Whenever contaminated laundry is wet and presents a reasonable
likelihood of soak-through of or leakage from the bag or container, the
laundry shall be placed and transported in bags or containers which
prevent soak-through and/or leakage of fluids to the exterior.
(B) The employer shall ensure that employees who have contact with
contaminated laundry wear protective gloves and other appropriate
personal protective equipment.
(C) When a facility ships contaminated laundry off-site to a second
facility which does not utilize Universal Precautions in the handling of
all laundry, the facility generating the contaminated laundry must place
such laundry in bags or containers which are labeled or color-coded in
accordance with paragraph (g)(1)(i).
(e) HIV and HBV Research Laboratories and Production Facilities. (1)
This paragraph applies to research laboratories and production
facilities engaged in the culture, production, concentration,
experimentation, and manipulation of HIV and HBV. It does not apply to
clinical or diagnostic laboratories engaged solely in the analysis of
blood, tissues, or organs. These requirements apply in addition to the
other requirements of the standard.
(2) Research laboratories and production facilities shall meet the
(i) Standard microbiological practices. All regulated waste shall
either be incinerated or decontaminated by a method such as autoclaving
known to effectively destroy bloodborne pathogens.
(ii) Special practices. (A) Laboratory doors shall be kept closed
when work involving HIV or HBV is in progress.
(B) Contaminated materials that are to be decontaminated at a site
from the work area shall be placed in a durable, leakproof, labeled or
color-coded container that is closed before being removed from the work
(C) Access to the work area shall be limited to authorized persons.
Written policies and procedures shall be established whereby only
persons who have been advised of the potential biohazard, who meet any
specific entry requirements, and who comply with all entry and exit
procedures shall be allowed to enter the work areas and animal rooms.
(D) When other potentially infectious materials or infected animals
are present in the work area or containment module, a hazard warning
sign incorporating the universal biohazard symbol shall be posted on all
access doors. The hazard warning sign shall comply with paragraph
(g)(1)(ii) of this standard.
(E) All activities involving other potentially infectious materials
shall be conducted in biological safety cabinets or other physical-
containment devices within the containment module. No work with these
other potentially infectious materials shall be conducted on the open
(F) Laboratory coats, gowns, smocks, uniforms, or other appropriate
protective clothing shall be used in the work area and animal rooms.
Protective clothing shall not be worn outside of the work area and shall
be decontaminated before being laundered.
(G) Special care shall be taken to avoid skin contact with other
potentially infectious materials. Gloves shall be worn when handling
infected animals and when making hand contact with other potentially
infectious materials is unavoidable.
(H) Before disposal all waste from work areas and from animal rooms
shall either be incinerated or decontaminated by a method such as
autoclaving known to effectively destroy bloodborne pathogens.
(I) Vacuum lines shall be protected with liquid disinfectant traps
and high-efficiency particulate air (HEPA) filters or filters of
equivalent or superior efficiency and which are checked routinely and
maintained or replaced as necessary.
(J) Hypodermic needles and syringes shall be used only for
parenteral injection and aspiration of fluids from laboratory animals
and diaphragm bottles. Only needle-locking syringes or disposable
syringe-needle units (i.e., the needle is integral to the syringe) shall
be used for the injection or aspiration of other potentially infectious
materials. Extreme caution shall be used when handling needles and
syringes. A needle shall not be bent, sheared, replaced in the sheath or
guard, or removed from the syringe following use. The needle and syringe
shall be promptly placed in a puncture-resistant container and
autoclaved or decontaminated before reuse or disposal.
(K) All spills shall be immediately contained and cleaned up by
appropriate professional staff or others properly trained and equipped
to work with potentially concentrated infectious materials.
(L) A spill or accident that results in an exposure incident shall
be immediately reported to the laboratory director or other responsible
(M) A biosafety manual shall be prepared or adopted and periodically
reviewed and updated at least annually or more often if necessary.
Personnel shall be advised of potential hazards, shall be required to
read instructions on practices and procedures, and shall be required to
(iii) Containment equipment. (A) Certified biological safety
cabinets (Class I, II, or III) or other appropriate combinations of
personal protection or physical containment devices, such as special
protective clothing, respirators, centrifuge safety cups, sealed
centrifuge rotors, and containment caging for animals, shall be used for
all activities with other potentially infectious materials that pose a
threat of exposure to droplets, splashes, spills, or aerosols.
(B) Biological safety cabinets shall be certified when installed,
whenever they are moved and at least annually.
(3) HIV and HBV research laboratories shall meet the following
(i) Each laboratory shall contain a facility for hand washing and an
eye wash facility which is readily available within the work area.
(ii) An autoclave for decontamination of regulated waste shall be
(4) HIV and HBV production facilities shall meet the following
(i) The work areas shall be separated from areas that are open to
unrestricted traffic flow within the building. Passage through two sets
of doors shall be the basic requirement for entry into the work area
from access corridors or other contiguous areas. Physical separation of
the high-containment work area from access corridors or other areas or
activities may also be provided by a double-doored clothes-change room
(showers may be included), airlock, or other access facility that
requires passing through two sets of doors before entering the work
(ii) The surfaces of doors, walls, floors and ceilings in the work
area shall be water resistant so that they can be easily cleaned.
Penetrations in these surfaces shall be sealed or capable of being
sealed to facilitate decontamination.
(iii) Each work area shall contain a sink for washing hands and a
readily available eye wash facility. The sink shall be foot, elbow, or
automatically operated and shall be located near the exit door of the
(iv) Access doors to the work area or containment module shall be
(v) An autoclave for decontamination of regulated waste shall be
available within or as near as possible to the work area.
(vi) A ducted exhaust-air ventilation system shall be provided. This
system shall create directional airflow that draws air into the work
area through the entry area. The exhaust air shall not be recirculated
to any other area of the building, shall be discharged to the outside,
and shall be dispersed away from occupied areas and air intakes. The
proper direction of the airflow shall be verified (i.e., into the work
(5) Training Requirements. Additional training requirements for
employees in HIV and HBV research laboratories and HIV and HBV
production facilities are specified in paragraph (g)(2)(ix).
(f) Hepatitis B vaccination and post-exposure evaluation and follow-
up--(1) General. (i) The employer shall make available the hepatitis B
vaccine and vaccination series to all employees who have occupational
exposure, and post-exposure evaluation and follow-up to all employees
who have had an exposure incident.
(ii) The employer shall ensure that all medical evaluations and
procedures including the hepatitis B vaccine and vaccination series and
post-exposure evaluation and follow-up, including prophylaxis, are:
(A) Made available at no cost to the employee;
(B) Made available to the employee at a reasonable time and place;
(C) Performed by or under the supervision of a licensed physician or
by or under the supervision of another licensed healthcare professional;
(D) Provided according to recommendations of the U.S. Public Health
Service current at the time these evaluations and procedures take place,
except as specified by this paragraph (f).
(iii) The employer shall ensure that all laboratory tests are
conducted by an accredited laboratory at no cost to the employee.
(2) Hepatitis B Vaccination. (i) Hepatitis B vaccination shall be
made available after the employee has received the training required in
paragraph (g)(2)(vii)(I) and within 10 working days of initial
assignment to all employees who have occupational exposure unless the
employee has previously received the complete hepatitis B vaccination
series, antibody testing has revealed that the employee is immune, or
the vaccine is contraindicated for medical reasons.
(ii) The employer shall not make participation in a prescreening
program a prerequisite for receiving hepatitis B vaccination.
(iii) If the employee initially declines hepatitis B vaccination but
at a later date while still covered under the standard decides to accept
the vaccination, the employer shall make available hepatitis B
vaccination at that time.
(iv) The employer shall assure that employees who decline to accept
hepatitis B vaccination offered by the employer sign the statement in
(v) If a routine booster dose(s) of hepatitis B vaccine is
recommended by the U.S. Public Health Service at a future date, such
booster dose(s) shall be made available in accordance with section
(3) Post-exposure Evaluation and Follow-up. Following a report of an
exposure incident, the employer shall make immediately available to the
exposed employee a confidential medical evaluation and follow-up,
including at least the following elements:
(i) Documentation of the route(s) of exposure, and the circumstances
under which the exposure incident occurred;
(ii) Identification and documentation of the source individual,
unless the employer can establish that identification is infeasible or
prohibited by state or local law;
(A) The source individual's blood shall be tested as soon as
feasible and after consent is obtained in order to determine HBV and HIV
infectivity. If consent is not obtained, the employer shall establish
that legally required consent cannot be obtained. When the source
individual's consent is not required by law, the source individual's
blood, if available, shall be tested and the results documented.
(B) When the source individual is already known to be infected with
HBV or HIV, testing for the source individual's known HBV or HIV status
need not be repeated.
(C) Results of the source individual's testing shall be made
available to the exposed employee, and the employee shall be informed of
applicable laws and regulations concerning disclosure of the identity
and infectious status of the source individual.
(iii) Collection and testing of blood for HBV and HIV serological
(A) The exposed employee's blood shall be collected as soon as
feasible and tested after consent is obtained.
(B) If the employee consents to baseline blood collection, but does
not give consent at that time for HIV serologic testing, the sample
shall be preserved for at least 90 days. If, within 90 days of the
exposure incident, the employee elects to have the baseline sample
tested, such testing shall be done as soon as feasible.
(iv) Post-exposure prophylaxis, when medically indicated, as
recommended by the U.S. Public Health Service;
(v) Counseling; and
(vi) Evaluation of reported illnesses.
(4) Information Provided to the Healthcare Professional. (i) The
employer shall ensure that the healthcare professional responsible for
the employee's Hepatitis B vaccination is provided a copy of this
(ii) The employer shall ensure that the healthcare professional
evaluating an employee after an exposure incident is provided the
(A) A copy of this regulation;
(B) A description of the exposed employee's duties as they relate to
the exposure incident;
(C) Documentation of the route(s) of exposure and circumstances
under which exposure occurred;
(D) Results of the source individual's blood testing, if available;
(E) All medical records relevant to the appropriate treatment of the
employee including vaccination status which are the employer's
responsibility to maintain.
(5) Healthcare Professional's Written Opinion. The employer shall
obtain and provide the employee with a copy of the evaluating healthcare
professional's written opinion within 15 days of the completion of the
(i) The healthcare professional's written opinion for Hepatitis B
vaccination shall be limited to whether Hepatitis B vaccination is
indicated for an employee, and if the employee has received such
(ii) The healthcare professional's written opinion for post-exposure
evaluation and follow-up shall be limited to the following information:
(A) That the employee has been informed of the results of the
(B) That the employee has been told about any medical conditions
resulting from exposure to blood or other potentially infectious
materials which require further evaluation or treatment. (iii) All other
findings or diagnoses
shall remain confidential and shall not be included in the written
(6) Medical recordkeeping. Medical records required by this standard
shall be maintained in accordance with paragraph (h)(1) of this section.
(g) Communication of hazards to employees--(1) Labels and signs--(i)
Labels. (A) Warning labels shall be affixed to containers of regulated
waste, refrigerators and freezers containing blood or other potentially
infectious material; and other containers used to store, transport or
ship blood or other potentially infectious materials, except as provided
in paragraph (g)(1)(i)(E), (F) and (G).
(B) Labels required by this section shall include the following
[GRAPHIC] [TIFF OMITTED] TC28OC91.018
(C) These labels shall be fluorescent orange or orange-red or
predominantly so, with lettering and symbols in a contrasting color.
(D) Labels shall be affixed as close as feasible to the container by
string, wire, adhesive, or other method that prevents their loss or
(E) Red bags or red containers may be substituted for labels.
(F) Containers of blood, blood components, or blood products that
are labeled as to their contents and have been released for transfusion
or other clinical use are exempted from the labeling requirements of
(G) Individual containers of blood or other potentially infectious
materials that are placed in a labeled container during storage,
transport, shipment or disposal are exempted from the labeling
(H) Labels required for contaminated equipment shall be in
accordance with this paragraph and shall also state which portions of
the equipment remain contaminated.
(I) Regulated waste that has been decontaminated need not be labeled
(ii) Signs. (A) The employer shall post signs at the entrance to
work areas specified in paragraph (e), HIV and HBV Research Laboratory
and Production Facilities, which shall bear the following legend:
[GRAPHIC] [TIFF OMITTED] TC28OC91.019
(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other responsible
(B) These signs shall be fluorescent orange-red or predominantly so,
with lettering and symbols in a contrasting color.
(2) Information and Training. (i) Employers shall ensure that all
employees with occupational exposure participate in a training program
which must be provided at no cost to the employee and during working
(ii) Training shall be provided as follows:
(A) At the time of initial assignment to tasks where occupational
exposure may take place;
(B) Within 90 days after the effective date of the standard; and
(C) At least annually thereafter.
(iii) For employees who have received training on bloodborne
pathogens in the year preceding the effective date of the standard, only
training with respect to the provisions of the standard which were not
included need be provided.
(iv) Annual training for all employees shall be provided within one
year of their previous training.
(v) Employers shall provide additional training when changes such as
modification of tasks or procedures or
institution of new tasks or procedures affect the employee's
occupational exposure. The additional training may be limited to
addressing the new exposures created.
(vi) Material appropriate in content and vocabulary to educational
level, literacy, and language of employees shall be used.
(vii) The training program shall contain at a minimum the following
(A) An accessible copy of the regulatory text of this standard and
an explanation of its contents;
(B) A general explanation of the epidemiology and symptoms of
(C) An explanation of the modes of transmission of bloodborne
(D) An explanation of the employer's exposure control plan and the
means by which the employee can obtain a copy of the written plan;
(E) An explanation of the appropriate methods for recognizing tasks
and other activities that may involve exposure to blood and other
potentially infectious materials;
(F) An explanation of the use and limitations of methods that will
prevent or reduce exposure including appropriate engineering controls,
work practices, and personal protective equipment;
(G) Information on the types, proper use, location, removal,
handling, decontamination and disposal of personal protective equipment;
(H) An explanation of the basis for selection of personal protective
(I) Information on the hepatitis B vaccine, including information on
its efficacy, safety, method of administration, the benefits of being
vaccinated, and that the vaccine and vaccination will be offered free of
(J) Information on the appropriate actions to take and persons to
contact in an emergency involving blood or other potentially infectious
(K) An explanation of the procedure to follow if an exposure
incident occurs, including the method of reporting the incident and the
medical follow-up that will be made available;
(L) Information on the post-exposure evaluation and follow-up that
the employer is required to provide for the employee following an
(M) An explanation of the signs and labels and/or color coding
required by paragraph (g)(1); and
(N) An opportunity for interactive questions and answers with the
person conducting the training session.
(viii) The person conducting the training shall be knowledgeable in
the subject matter covered by the elements contained in the training
program as it relates to the workplace that the training will address.
(ix) Additional Initial Training for Employees in HIV and HBV
Laboratories and Production Facilities. Employees in HIV or HBV research
laboratories and HIV or HBV production facilities shall receive the
following initial training in addition to the above training
(A) The employer shall assure that employees demonstrate proficiency
in standard microbiological practices and techniques and in the
practices and operations specific to the facility before being allowed
to work with HIV or HBV.
(B) The employer shall assure that employees have prior experience
in the handling of human pathogens or tissue cultures before working
with HIV or HBV.
(C) The employer shall provide a training program to employees who
have no prior experience in handling human pathogens. Initial work
activities shall not include the handling of infectious agents. A
progression of work activities shall be assigned as techniques are
learned and proficiency is developed. The employer shall assure that
employees participate in work activities involving infectious agents
only after proficiency has been demonstrated.
(h) Recordkeeping--(1) Medical Records. (i) The employer shall
establish and maintain an accurate record for each employee with
occupational exposure, in accordance with 29 CFR 1910.20.
(ii) This record shall include:
(A) The name and social security number of the employee;
(B) A copy of the employee's hepatitis B vaccination status
dates of all the hepatitis B vaccinations and any medical records
relative to the employee's ability to receive vaccination as required by
(C) A copy of all results of examinations, medical testing, and
follow-up procedures as required by paragraph (f)(3);
(D) The employer's copy of the healthcare professional's written
opinion as required by paragraph (f)(5); and
(E) A copy of the information provided to the healthcare
professional as required by paragraphs (f)(4)(ii)(B)(C) and (D).
(iii) Confidentiality. The employer shall ensure that employee
medical records required by paragraph (h)(1) are:
(A) Kept confidential; and
(B) Not disclosed or reported without the employee's express written
consent to any person within or outside the workplace except as required
by this section or as may be required by law.
(iv) The employer shall maintain the records required by paragraph
(h) for at least the duration of employment plus 30 years in accordance
with 29 CFR 1910.20.
(2) Training Records. (i) Training records shall include the
(A) The dates of the training sessions;
(B) The contents or a summary of the training sessions;
(C) The names and qualifications of persons conducting the training;
(D) The names and job titles of all persons attending the training
(ii) Training records shall be maintained for 3 years from the date
on which the training occurred.
(3) Availability. (i) The employer shall ensure that all records
required to be maintained by this section shall be made available upon
request to the Assistant Secretary and the Director for examination and
(ii) Employee training records required by this paragraph shall be
provided upon request for examination and copying to employees, to
employee representatives, to the Director, and to the Assistant
(iii) Employee medical records required by this paragraph shall be
provided upon request for examination and copying to the subject
employee, to anyone having written consent of the subject employee, to
the Director, and to the Assistant Secretary in accordance with 29 CFR
(4) Transfer of Records. (i) The employer shall comply with the
requirements involving transfer of records set forth in 29 CFR
(ii) If the employer ceases to do business and there is no successor
employer to receive and retain the records for the prescribed period,
the employer shall notify the Director, at least three months prior to
their disposal and transmit them to the Director, if required by the
Director to do so, within that three month period.
(i) Dates--(1) Effective Date. The standard shall become effective
on March 6, 1992.
(2) The Exposure Control Plan required by paragraph (c) of this
section shall be completed on or before May 5, 1992.
(3) Paragraph (g)(2) Information and Training and (h) Recordkeeping
shall take effect on or before June 4, 1992.
(4) Paragraphs (d)(2) Engineering and Work Practice Controls, (d)(3)
Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and HBV
Research Laboratories and Production Facilities, (f) Hepatitis B
Vaccination and Post-Exposure Evaluation and Follow-up, and (g) (1)
Labels and Signs, shall take effect July 6, 1992.
Appendix A to Section 1910.1030--Hepatitis B Vaccine Declination
I understand that due to my occupational exposure to blood or other
potentially infectious materials I may be at risk of acquiring hepatitis
B virus (HBV) infection. I have been given the opportunity to be
vaccinated with hepatitis B vaccine, at no charge to myself. However, I
decline hepatitis B vaccination at this time. I understand that by
declining this vaccine, I continue to be at risk of acquiring hepatitis
B, a serious disease. If in the future I continue to have occupational
exposure to blood or other potentially infectious materials and I want
to be vaccinated
with hepatitis B vaccine, I can receive the vaccination series at no
charge to me.
[56 FR 64175, Dec. 6, 1991, as amended at 57 FR 12717, Apr. 13, 1992; 57
FR 29206, July 1, 1992; 61 FR 5508, Feb. 13, 1996]