The Occupational Safety and Health Administration Bloodborne Pathogens Standard∗
Part 1910 of title 29 of the Code of Federal Regulations is amended as follows:
1. The general authority citation for subpart Z of 29 CFR part 1910 continues to read as follows and a new citation for 1910.1030 is added:
Authority: Secs. 6 and 8. Occupational Safety and Health Act. 29 U.S.C. 655, 657, Secretary of Labor’s Orders Nos. 12-71 (36 FR 8754). 8-76 (41 FR 25059), or 9-83 (48 FR 35736), as applicable; and 20 CFR part 1911.
Section 1910.1030 also issued under 29 U.S.C. 653.
2. Section 1910.1030 is added to read as follows:
(Note: The 2001 needlestick prevention additions to this standard are underlined.)
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 that 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, 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.
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 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).
(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 that affect occupational exposure and to reflect new or revised employee positions with occupational exposure. The review and update of such plan 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.
(v) The Exposure Control Plan shall be made available to the Assistant Secretary and the Director upon request for examination and copying.
(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 tasks 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.
(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 that 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 recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical 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:
(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 that 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 that is puncture-resistant in addition to the above characteristics.
(xiv) Equipment that 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 judgment, the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences 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.
(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:
(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).
(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 that 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.
(A) Contaminated Sharps Discarding and Containment.
(1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are:
(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);
(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:
(4) Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.
(B) Other Regulated Waste Containment.
(1) Regulated waste shall be placed in containers which are:
(ii) Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping;
(iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) of 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:
(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.
(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 or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior.
(B) The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment.
(C) When a facility ships contaminated laundry off-site to a second facility which does not utilize Universal Precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1)(i).
(e) HIV and HBV Research Laboratories and Production Facilities. See original publication for this information.
(f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up-
(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.
(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 (Box H-1).
(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;
(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.
(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 that 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-
(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:
BIOHAZARD (see Figure 8-1, p.89)
(C) These labels shall be fluorescent orange or orange-red or predominantly so, with lettering or symbols in a contrasting color.
(D) Labels required 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.
(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:
(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 or symbols in a contrasting color.
(i) Employers shall ensure that all employees with occupational exposure participate in a training program that 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
(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 that 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 co nducting 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 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.
(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:
(B) Are 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.
(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.
(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 in accordance with 29 CFR 1910.20.
(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.
(i) The employer shall comply with the requirements involving transfer of records set forth in 29 CFR 1910.20(h).
(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 s o, within that three month period.
(5) Sharps injury log [Note: Dentistry is exempt from this portion rule and need not keep a sharps injury log unless an incident results in a death or hospitalization of three or more employees. This part of the Standard is included here only for completeness].
(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 a 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
(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 1904.6 [Note: Dentistry is excluded as noted previously.
(iii) The sharps injury log shall be maintained for the period required by 29 CFR 1904.6.
(1) Effective Date. The standard shall become effective on March 6, 1992.
(2) The Exposure Control Plan required by paragraph (c)(2) 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.
∗Reprinted from Department of Labor, Occupational Safety and Health Administration: 29 CFR Part 1910.1030. Occupational exposure to bloodborne pathogens; final rule, Fed Regist 56(235):645175-645182, 1991; with needlestick prevention update of 2001 added.