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ELECTRONIC CODE OF FEDERAL REGULATIONS
e-CFR Data is current as of October 1, 2014
Title 29 → Subtitle B → Chapter XVII → Part 1910 → Subpart Z → §1910.1030
Title 29: Labor
PART 1910—OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED)
Subpart Z—Toxic and Hazardous Substances
§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 apply:
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 infectious materials.
Contaminated means the presence or the reasonably anticipated presence of blood or other
potentially infectious materials on an item or surface.
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 disposal.
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,
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safer medical devices, such as sharps with engineered sharps injury protections and needleless
systems) 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 employee's duties.
Handwashing facilities means a facility providing an adequate supply of running potable water,
soap, and single-use towels or air-drying machines.
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.
Needleless systems means a device that does not use needles for:
(1) The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access
is established;
(2) The administration of medication or fluids; or
(3) Any other procedure involving the potential for occupational exposure to bloodborne
pathogens due to percutaneous injuries from contaminated sharps.
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 employee's duties.
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 body fluids;
(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.
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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 infectious materials.
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 production facilities.
Sharps with engineered sharps injury protections means a nonneedle sharp or a needle device
used for withdrawing body fluids, accessing a vein or artery, or administering medications or other
fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure
incident.
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 components.
Sterilize means the use of a physical or chemical procedure to destroy all microbial life including
highly resistant bacterial endospores.
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 elements:
(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 PostExposure 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).
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(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. The review and update of such
plans shall also:
(A) Reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens;
and
(B) Document annually consideration and implementation of appropriate commercially available
and effective safer medical devices designed to eliminate or minimize occupational exposure.
(v) An employer, who is required to establish an Exposure Control Plan shall solicit input from
non-managerial employees responsible for direct patient care who are potentially exposed to injuries
from contaminated sharps in the identification, evaluation, and selection of effective engineering and
work practice controls and shall document the solicitation in the Exposure Control Plan.
(vi) The Exposure Control Plan shall be made available to the Assistant Secretary and the
Director upon request for examination and copying.
(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.
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(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
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shipping and is labeled or color-coded according to the requirements of this standard.
(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 remain contaminated.
(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 employee, appropriate 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
occurances in the future.
(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.
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(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 nonintact 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 compromised.
(D) If an employer in a volunteer blood donation center judges that routine gloving for all
phlebotomies is not necessary then the employer shall:
(1) Periodically reevaluate this policy;
(2) Make gloves available to all employees who wish to use them for phlebotomy;
(3) Not discourage the use of gloves for phlebotomy; and
(4) Require that gloves be used for phlebotomy in the following circumstances:
(i) When the employee has cuts, scratches, or other breaks in his or her skin;
(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 reasonably anticipated.
(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 infectious materials.
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(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 last cleaning.
(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 contamination.
(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:
(i) Closable;
(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, or shipping;
(ii) Placed in a secondary container if leakage is possible. The second container shall be:
(A) Closable;
(B) Constructed to contain all contents and prevent leakage during handling, storage, transport, or
shipping; and
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(C) Labeled or color-coded according to paragraph (g)(1)(i) of this standard.
(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:
(i) Closable;
(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 shall be:
(i) Closable;
(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 colorcoded 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
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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 following criteria:
(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 away 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 area.
(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 bench.
(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
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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 person.
(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 follow them.
(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 criteria:
(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 available.
(4) HIV and HBV production facilities shall meet the following criteria:
(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 area.
(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 work area.
(iv) Access doors to the work area or containment module shall be self-closing.
(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
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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 area).
(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; and
(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 appendix A.
(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 (f)
(1)(ii).
(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:
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(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 status;
(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 regulation.
(ii) The employer shall ensure that the healthcare professional evaluating an employee after an
exposure incident is provided the following information:
(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; and
(E) All medical records relevant to the appropriate treatment of the employee including vaccination
status which are the employer's responsibility to maintain.
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(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 evaluation.
(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
vaccination.
(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 evaluation; and
(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 report.
(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 legend:
View or download PDF
(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 unintentional removal.
(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 paragraph (g).
(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
requirement.
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(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 or color-coded.
(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:
View or download PDF
(Name of the Infectious Agent)
(Special requirements for entering the area)
(Name, telephone number of the laboratory director or other responsible person.)
(B) These signs shall be fluorescent orange-red or predominantly so, with lettering and symbols in
a contrasting color.
(2) Information and Training. (i) The employer shall train each employee with occupational
exposure in accordance with the requirements of this section. Such training must be provided at no
cost to the employee and during working hours. The employer shall institute a training program and
ensure employee participation in the program.
(ii) Training shall be provided as follows:
(A) At the time of initial assignment to tasks where occupational exposure may take place;
(B) At least annually thereafter.
(iii) [Reserved]
(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 elements:
(A) An accessible copy of the regulatory text of this standard and an explanation of its contents;
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(B) A general explanation of the epidemiology and symptoms of bloodborne diseases;
(C) An explanation of the modes of transmission of bloodborne pathogens;
(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 equipment;
(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 charge;
(J) Information on the appropriate actions to take and persons to contact in an emergency
involving blood or other potentially infectious materials;
(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 exposure incident;
(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 requirements.
(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
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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
1910.1020.
(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 including the dates of all the hepatitis
B vaccinations and any medical records relative to the employee's ability to receive vaccination as
required by paragraph (f)(2);
(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 1910.1020.
(2) Training Records. (i) Training records shall include the following information:
(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; and
(D) The names and job titles of all persons attending the training sessions.
(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 copying.
(ii) Employee training records required by this paragraph shall be provided upon request for
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examination and copying to employees, to employee representatives, to the Director, and to the
Assistant Secretary.
(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 1910.1020.
(4) Transfer of Records. The employer shall comply with the requirements involving transfer of
records set forth in 29 CFR 1910.1020(h).
(5) Sharps injury log. (i) The employer shall establish and maintain a sharps injury log for the
recording of percutaneous injuries from contaminated sharps. The information in the sharps injury log
shall be recorded and maintained in such manner as to protect the confidentiality of the injured
employee. The sharps injury log shall contain, at a minimum:
(A) The type and brand of device involved in the incident,
(B) The department or work area where the exposure incident occurred, and
(C) An explanation of how the incident occurred.
(ii) The requirement to establish and maintain a sharps injury log shall apply to any employer who
is required to maintain a log of occupational injuries and illnesses under 29 CFR part 1904.
(iii) The sharps injury log shall be maintained for the period required by 29 CFR 1904.33.
(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) Paragraphs (g)(2) Information and Training and (h) Recordkeeping of this section 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
of this section, shall take effect July 6, 1992.
APPENDIX A TO SECTION 1910.1030—HEPATITIS B VACCINE DECLINATION (MANDATORY)
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; 66 FR 5325, Jan. 18, 2001; 71 FR 16672, 16673, Apr. 3, 2006; 73 FR 75586, Dec. 12,
2008; 76 FR 33608, June 8, 2011; 76 FR 80740, Dec. 27, 2011; 77 FR 19934, Apr. 3, 2012]
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File Type | application/pdf |
File Title | http://www.ecfr.gov/cgi-bin/text-idx?SID=7e4fc0e057f6d68c886ede |
Author | RShowalter |
File Modified | 2014-10-03 |
File Created | 2014-10-03 |