Courtesy of: 			Wholesale Body Bags nc.
Direct Link to OSHA 
[Code of Federal Regulations]
[Title 29, Volume 6]
[Revised as of July 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 29CFR1910.1030]

[Page 260-273]
 
                             TITLE 29--LABOR
 
CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT 
                                OF LABOR
 
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 
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

[[Page 261]]

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, 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 hot 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.
    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

[[Page 262]]

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 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. 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.

[[Page 263]]

    (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.

[[Page 264]]

    (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 
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 occurences 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.
    (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.

[[Page 265]]

    (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.
    (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.

[[Page 266]]

    (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
    (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 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

[[Page 267]]

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 
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 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.

[[Page 268]]

    (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 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;

[[Page 269]]

    (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:
    (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;

[[Page 270]]

    (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.
    (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:
[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 
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.
    (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:

[[Page 271]]

[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 
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) 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 
hours.
    (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 
elements:
    (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 
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

[[Page 272]]

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 
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 
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 1910.20.
    (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 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 
1910.20.
    (4) Transfer of Records. (i) The employer shall comply with the 
requirements involving transfer of records set forth in 29 CFR 
1910.20(h).

[[Page 273]]

    (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.
    (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 1904.
    (iii) The sharps injury log shall be maintained for the period 
required by 29 CFR 1904.6.

    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]
Reference Links:

http://www.access.gpo.gov/nara/cfr/waisidx_99/29cfr1910a_99.html

http://www.ehs.neu.edu/blood3/

http://www.cremationassociation.org/html/environment.html

 

 

Transfercare Protectors Inc.

Executive Offices

27 Katherine Place

Oakdale, NY 11769

718-336-5354

631-218-3492