BIOSAFETY PLAN
POLICY & PURPOSE
This Biosafety Plan provides a framework and operational guidelines for handling biological agents and potential human pathogens in a Biosafety Level 2 (BSL-2) setting. This Plan contains the Zoetis Union Cit Exposure Control Plan as required by Cal/OSHA’s Bloodborne Pathogens Standard.
This Plan is consistent with guidelines established in the publication Biosafety in the Microbiological and Biomedical Laboratories (BMBL). Waste handling procedures described in this document follow the requirements of the California Medical Waste Management Act. This document is intended to be dynamic and will be modified to reflect significant changes in work practices and operations taking place at Zoetis Union City.
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RESPONSIBILITIES
Under the Bloodborne Pathogens Standard the company is required to offer Hepatitis B vaccinations to colleagues who are potentially at risk at the time of hire, and to ensure that Zoetis Union City complies with applicable rules, regulations, and industry guidelines related to the Biosafety and Bloodborne Pathogens program.
Colleagues who handle blood and other biohazardous materials are expected to become familiar with the procedures in this Plan and the accompanying Exposure Control Plan. Colleagues who work with human blood or human-derived materials are also responsible for scheduling hepatitis B vaccinations, or for having a Declination Form on file with EH&S. This is explained in further detail in the Blood Borne Pathogens section.
TRAINING
All colleagues who have occupational exposure to bloodborne pathogens receive initial and annual refresher training conducted by EH&S Department. Training materials are available at the EH&S Department.
PROGRAM REQUIREMENTS
Principles of Biosafety
The underlying principle of biosafety involves containment of the material. The 3 basic components to containment are:
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Laboratory Practices and Techniques: Safe work practices and laboratory techniques are procedural and involve experience and knowledge of the hazardous materials being handled.
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Primary Barriers: Primary barriers refer to containment practices and devices that are applied in the lab which contribute toward the prevention of exposures and the release of contaminants outside the lab. These containment measures are implemented by employees and in many cases, include containment devices, such as biosafety cabinets.
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Secondary Barrier: The part of the facility design that involves support and infrastructure to the work area that is intended to protect the community from infectious agents which may be released from the laboratory.
Biosafety Levels
Infectious and biologically hazardous agents are grouped into risk groups 1 to 4 based on their virulent properties and characteristics. Each risk group has a corresponding biosafety level (BSL) under which proper containment of the agent and safe work practices apply. The highest hazardous material in a work area dictates the biosafety level. Each biosafety level builds upon safety provisions of the preceding biosafety level.
Labs that handle human blood, cells, tissue, or other potentially infectious body fluids must function at BSL-2 because these materials are capable of harboring pathogens. Animal pathogens are handled in the R&D lab and also require working under BSL-2 containment practices.
Biosafety levels establish a regimen for containment by incorporating the use of engineering controls, administrative controls, and personal protective equipment. Summaries of biosafety levels applicable to the site are presented in Table 4. Information on the other biosafety levels can be found in the Biosafety and Microbiology in Biomedical Laboratories (BMBL), Section 2.1
Biosafety Level 2 (BSL-2)
BSL-2 is a suitable level of containment for most Zoetis Union City work areas where employees handle human blood, blood controls, and animal samples. BSL-2 accommodates the handling of materials known to cause disease in humans, so containment measures are increased from those of a BSL-1 lab.
The most common bloodborne pathogens include HIV-1, Hepatitis B and Hepatitis C viruses, which are typically transmitted in an occupational setting through bloodborne exposures such as breaks in the skin or exposure through open wounds. Blood can also harbor airborne viruses such as influenza or tuberculosis, requiring the application of BSL-2 practices by handling airborne pathogens inside of a biosafety cabinet. An Exposure Control Plan is required for handling human-derived agents and is presented in the section on Blood Borne Pathogens..
Primary containment in a BSL-2 setting includes:
Access limited to individuals who have fulfilled all entry requirements (i.e., training, immunizations, PPE). At Zoetis Union City this may mean that for the R&D Lab:
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Number of people with access is capped at a specific number. If someone from a particular group needs access that does not currently have approval, another person will have to forfeit access to allow the new person access.
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Supervisor of the individual must justify the critical need for the individual to work in the R&D Lab.
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Access must be granted, in writing by the CTO or Senior Director in R&D prior to entry.
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Sharing of access codes between members of your team is strictly forbidden.
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Gaining access to the R&D lab through unsecured entrances is also not appropriate and is a violation of safe work practices.
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Removing equipment from the lab, without explicit permission of the CTO, even for a brief time, puts all Zoetis team members at risk of harm by potential exposure to pathogens contained in the R&D Lab.
NOTE: Temporary exceptions to the above requirements may be made for facilities or ERT personnel in an emergency response situation.
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Visitors must be supervised by a properly trained colleague .
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Hepatitis B immunizations or titer tests are provided where human blood or other human-derived materials are handled.
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Copy of Biosafety in the Microbiological and Biomedical Laboratory (BMBL) in work areas, as a reference, where employees handle pathogenic materials.
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Training in the specific materials or agents handled.
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A sharps handling program.
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Biohazard label posted at the entrance, including:
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The names of the agents listed
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The name and phone number of the work area manager
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Biosafety cabinets of at least a Class II design that are maintained and certified at least annually by a qualified vendor.
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Face shields, dust and/or mist respirators, and other appropriate protection where the potential for aerosol generation is increased.
Animal samples are not bloodborne pathogens; however, they can contain pathogens or parasites capable of infecting humans. In the R&D lab the bio-hazards may be animal-borne and include media such as feces, urine, or serum. Some of the diseases that are transmittable between animals and humans require a vector, which commonly involves another organism, such as an insect, to cause the infection. Without a vector, many of these agents are not transmittable. However, there may be enteric bacteria in feces or urine that can cause illness in humans, if exposed. These media (feces, urine, etc.) must also be handled in a BSL-2 setting and treated as infectious until stabilized, inactivated, or the disease-causing agent is isolated.
Engineering Controls
Engineering controls are mechanical devices that separate the user from the materials that are handled. They include:
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Biological safety cabinets.
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Chemical exhaust hoods.
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Filtered pipette tips.
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Engineered sharps injury protection (discussed in section on Blood Borne Pathogens).
Zoetis Union City biosafety cabinets are in areas such as R&D. These cabinets are Class II, Type A, and are appropriate for the applications that are needed. A qualified vendor will certify the biological safety cabinets at least annually to ensure the units operate properly.
Administrative Controls
Procedures and work practices are intended to reduce an employee’s potential for exposure. For example, the direct disposal of contaminated sharps is a procedure that eliminates recapping needles, or otherwise placing oneself at risk of accidental self-inoculation. Other administrative controls may include, but are not limited to:
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Limiting access to work areas during sensitive operations
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A medical surveillance program.
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Decontamination and/or disinfection practices.
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Spill clean-up procedures.
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Good housekeeping practices.
Personal Protective Equipment
Personal protective equipment (PPE) includes protective clothing that is often used in combination with other safety equipment to prevent employee exposure from blood or other potentially infectious materials. Each work area has gowning requirements that include one or more of the following:
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Lab Coats/Smocks: A primary barrier that prevents clothes from being contaminated. Most labs and production areas require the use of lab coats, while support areas may establish slight variations to gowning requirements.
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Gloves: Nitrile and latex gloves are available in all labs. Latex gloves are used when handling biological materials or patients, whereas nitrile gloves offer greater protection and durability, and are recommended for chemical handling. Gloves must be impervious to the material being handled and cover all exposed skin.
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Eye and face protection: Safety glasses are placed outside select work locations and must be worn when required. These safety glasses provide side shields and a small brow guard that protects the eyes from errant droplets and small splashes.
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Closed-topped shoes: Protect all exposed skin when working in the lab. It is recommended that exposed skin be covered when working in the lab.
Personal protective equipment must be provided by the employer and must meet the following criteria:
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Must fit colleagues properly.
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Laundering and repair or replacement must be available.
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Proper disposal containers for contaminated equipment must be in place.
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Colleagues must be informed of limitations of PPE to remove potential misconceptions of the level of protection.
When new or additional PPE is issued, supervisors are required to train colleagues on its proper use and application. This is to ensure compliance with applicable OSHA regulations and helps colleagues understand the uses and limitations of PPE.
Practices and Techniques
Good lab practices and techniques are important in promoting safety and employees are expected to be knowledgeable in safe lab practices, or contact EH&S for guidance if they are unsure. Training, familiarity with written safety procedures, and implementing those techniques and practices in the lab are among the elements which accompany employee recognition of hazards and personal safety.
The following are basic rules for working with biohazardous materials:
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Do not:
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Eat or drink in these work settings.
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Apply cosmetics or lip balm, or chew gum; avoid other hand-to-face contact.
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Do:
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Manipulate liquids to avoid spills and minimize production of aerosols and droplets.
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Restrict the use of needles and syringes to procedures where there is no alternative. Use needles, syringes and other "sharps" carefully to avoid self-inoculation.
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Dispose of sharps in sharps containers immediately after use.
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Wear personal protective equipment that is appropriate to the agents being handled.
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Wash hands following the removal of gloves and immediately after handling infectious materials.
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Use only mechanical pipetting or suction devices; mouth pipetting is not allowed.
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Decontaminate work surfaces after use and immediately after spills.
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Keep children and pets out of biohazard handling areas.
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Colleagues are expected to apply safety practices that are appropriate to the agents they are handling and the biosafety level of the lab.
Risk Assessment
Risk assessments are periodically conducted to determine appropriate safety measures for a workplace or process. New bio-hazards, new assays, or new materials and procedures often undergo a risk assessment before they are handled in the lab or in production. Risk assessments look at the following factors:
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The route of transmission.
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The inherent hardiness of the agent.
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Susceptibility of the host to infection.
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Medical predispositions of employees.
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Prior immunity.
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Other personal factors
Bio-hazardous Waste Management
The California Medical Waste Management Act regulates biohazardous waste (also known as biomedical waste) in California. Biomedical waste is defined as laboratory waste that includes, but is not limited to:
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Human or animal-derived materials from medical and pathology laboratories.
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Cultures and stocks of infectious agents from research and industrial laboratories.
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Wastes from the production of bacteria, viruses, spores, live and attenuated vaccines used in human health care or research, discarded animal vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures.
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Human surgery specimens or tissues.
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Animal tissue, fluids, or carcasses.
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Pharmaceutical preparations including human and veterinary drugs, including chemotherapeutic drugs.
Bio-hazardous waste is managed by EHS department, and includes contracting with vendors, establishing waste profiles, and managing waste manifests. . Waste is accumulated in the hazardous waste room, which is labeled on the outside of the storage area with a bilingual sign (usually in English and Spanish) stating the following:
“Caution – Hazardous Waste Area – Unauthorized Persons Keep Out”
Solid Waste
All biohazardous waste that Zoetis Union City generates must be transferred to the biohazardous waste containers provided by the biohazardous waste vendor, located in the Waste Room.
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Solid waste usually consists of used rotors, sharps containers, paper, plastics, consumable goods, supplies, and other materials that have come in contact with potentially viable biological material such as blood, serum, blood controls, or anything derived from a human or animal. Each waste bin has a 37-gallon capacity and accommodates approximately 3 twenty pound bags of waste.
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California’s Medical Waste Management Act (MWMA) requires that biohazardous waste be stored only in red waste bags bearing the biohazard symbol, and must be contained in a rigid, leak-proof waste container bearing the biohazard symbol on the top and its front. The container must be covered when not in use.
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The biohazardous waste vendor is responsible for cleaning the inside surfaces and the inside lid of the waste container to prevent the spread of contamination. The biological waste vendor provides a tracking manifest that lists the number of bins picked up. A Zoetis Union City representative must sign these tracking documents.
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All colleagues who generate, handle, transport, or otherwise are involved in hazardous waste management must attend annual training in EPA waste requirements and in the methods of compliance for site-specific hazardous waste management.
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Colleagues who handle hazardous waste are required to wear the appropriate personal protective equipment (PPE). At a minimum, colleagues must wear appropriate protective gloves, safety glasses when splashing may occur, and closed-topped shoes.
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Open bags of waste are not permitted to be disposed of into the accumulation bins. Colleagues must close the bag with tape, twist ties, or by tying it prior to transport it to the hazardous waste accumulation room (HWAR).
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Solid waste may contain untreated liquid; therefore it is always appropriate to use a cart with absorbent bench paper underneath to catch any drips or leaks during transport through the building.
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California law states that once biohazardous waste is placed in the vendor’s container in the waste area, it must be removed within one week. Zoetis Uniion City vendor picks up waste twice weekly, currently on Tuesdays and Fridays. Waste must be completely contained in bags inside the vendor’s waste bin and covered during storage, even if the bin is only partially full.
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Vendor bins that weigh more than 61 pounds will be assessed an additional overweight surcharge,. A scale in the waste room can be used to determine if the waste limit is exceeded.
Liquid Waste
Liquid waste generally consists of spent blood or serum, waste from assays that were run on instruments or in the R&D and Quality Control labs. Liquid biohazard waste generated at Zoetis Union City is left over controls or blood from studies. This waste is minimal in quantity and is discarded in its original vial in the biohazard waste. If the liquid biohazardous waste is more than 50 milliliters it must be disinfected prior to sink disposal. Add enough household bleach to the liquid vessel until it comprises 10% of the total volume and allow the liquid to stand for at least 30 minutes in order to effectively deactivate potentially viable material before pouring it into the lab sink. Flush the materials with running water as the liquid is poured out. EH&S should be contacted if unsure about the disposal of Liquid biohazardous waste.
Sharps Disposal
Sharps include razor blades, needles and syringes, Pasteur and serological pipettes, glass vials (including empty or full control blood vials), broken glass, pipette tips, and any other materials capable of cutting or puncturing waste bags. Since they pose a risk of causing exposures and leaks, Sharps containers should be used instead. Sharps containers are made of rigid plastic and are labeled with the biohazard symbol. The basic requirements of sharps waste include:
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Sharps must not protrude from the opening of the container. Use sharps containers that will effectively hold the materials intended for disposal.
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When a sharps container is three-fourths full, close the lid and make sure that it is snapped shut. Dispose of the filled sharps container in biohazardous waste accumulation drums in the hazardous waste room.
Each functional area at the site will order its own sharps containers to accommodate the volume and type of sharps waste generated in that area.
Mixed Waste
“Mixed waste” is a combination of medical, hazardous, and non-medical waste and is subject to regulation as specified in hazardous waste statutes and regulations. It is Zoetis Union City responsibility to assess unique waste streams and to handle them according to legal requirements. It is the responsibility of all workers to properly segregate waste streams.
Emergency Response
Emergencies include spills and releases, exposures to biologically hazardous agents, and injuries involving biological hazards. Emergency procedures for biological exposures are covered in our Emergency Action Plan and post-exposure procedures are discussed in the Bloodborne Pathogens Exposure Control Plan.
The greatest concern to an employee after an exposure to human-derived materials is the potential for transmission of a disease-causing agent. The faster a physician obtains information about the source of exposure, the faster the physician can respond. This is critical in cases of exposure to HIV-contaminated blood or material, where the doctor has only a few hours to effectively administer prophylaxis
Biological Spill
Biological spills commonly involve liquids that contain potentially pathogenic materials. Follow the link for the procedure which should be followed after a spill.
Record Keeping
Zoetis Union City shall establish and maintain an accurate record for each colleague with occupational exposures to biohazardous agents and for occupational health programs in which colleagues are involved. This record must include:
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The name and personal information of the colleague. Personal medical information is kept on file in the colleague's Human Resources files.
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A copy of the colleague's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and Titer test results.
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A copy of all results of examinations, medical testing, and follow-up procedures, as required.
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The colleague's copy of the healthcare professional's written opinion from adverse exposures.
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The employer shall maintain the records for at least the duration of employment plus 30 years.
Any information provided to the healthcare professional regarding an colleague must be kept confidential and may not be disclosed outside the workplace.
REFERENCES/RESOURCES
DOCUMENTS/LINKS
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OSHA Standard 1910.1030 Bloodborne Pathogens
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California Health and Safety Code Sections 117600-118360 California Medical Waste Management Act (MWMA)
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National Institutes of Health
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Biosafety in the Microbiological and Biomedical Laboratory (BMBL)
GLOSSARY
Administrative Controls
Chemical Hygiene, BBP, Biosafety, HazCom
Controls include limiting the length of time an employee is exposed to hazardous atmospheres.
Animal waste
Biosafety
Animal carcasses, excrement, contaminated litter, or debris from the bodies of animals, such as feathers or dander.
Biohazardous Materials
BBP, Biosafety, ERT
Infectious agents, the products of infectious agents, or the components of infectious agents presenting a risk of injury or illness.
Biosafety Cabinet
BBP, Biosafety
A ventilated cabinet which serves as a primary containment device for operations involving biohazard materials.
Biosafety Cabinet - CLASS III
BBP, Biosafety
The Class III biosafety cabinet is a totally enclosed, negative pressure, ventilated cabinet of gas-tight construction. Operations within the Class III cabinet are conducted through protective gloves. Supply air is drawn into the cabinet through high-efficiency particulate air filters. Exhaust air is filtered by two high efficiency particulate air filters placed in series or by high efficiency particulate air filtration and incineration, and discharged to the outdoor environment without recirculation.
Biosafety Cabinet - Class I
BBP, Biosafety
The Class I biosafety cabinet is an open-fronted negative pressured ventilated cabinet with a minimum inward average face velocity at the work opening of at least 75 feet per minute. The exhaust air from the cabinet is filtered by a HEPA filter and discharged without recirculation.
Biosafety Cabinet - Class II
BBP, Biosafety
The Class II biosafety cabinet is an open-fronted, ventilated cabinet. Exhaust air is filtered with a high efficiency particulate air filter (HEPA). This cabinet provides HEPA-filtered downward airflow within the workspace. Class II Cabinets are further classified as type A, type B1, type B2 and type B3. Class II, type A biosafety cabinets may have positive pressure contaminated internal ducts and may exhaust HEPA-filtered air back into the laboratory. Shall provide a minimum inward average face velocity of 75 feet per minute at the work opening. Class II type B1 cabinets have all biologically contaminated internal ducts or plenums under negative pressure or surrounded by negative pressure ducts or plenums, exhaust HEPA filtered air through external ducts to space outside the laboratory, and have HEPA filtered down flow air composed largely of unrecirculated inflow air. Class II type B2 cabinets (also known as "total exhaust" cabinets) have all biologically contaminated internal ducts or plenums under negative pressure or surrounded by negative pressure ducts or plenums, exhaust HEPA filtered air through external ducts to space outside the laboratory, and have HEPA filtered downflow air drawn from the laboratory or outside air. Class II type B3 cabinets (also known as "convertible" cabinets) have all biologically contaminated internal ducts or plenums under negative pressure or surrounded by negative pressure ducts or plenums, exhaust HEPA filtered air through external ducts to space outside the laboratory, and have HEPA filtered downflow air that is a portion of the mixed downflow and inflow air from a common exhaust plenum.
Biosafety Level
BBP, Biosafety
Biosafety levels consist of laboratory practices and techniques, safety equipment, and a laboratory facility appropriate for the operations performed and the hazard posed by the particular biohazard material. The Centers for Disease Control (CDC) and the National Institute of Health (NIH) define the four biosafety levels in the publication, Biosafety in Microbiological and Biomedical Laboratories, 1988 and revisions, and recommend biosafety levels for particular pathogenic microorganisms.
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
BBP, Biosafety
Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition, CDC and National Institutes for Health, 2007, which is hereby, incorporated by reference for the purpose of establishing biosafety requirements in laboratories.
Biosecurity procedures
BBP, Biosafety
Control measures, such as traffic control, disinfection, and isolation, that are implemented to reduce the risk of transmission of infection into, from, or within an establishment. The purpose of biosecurity measures is to prevent direct or indirect animal-to-animal transmission of zoonotic ATPs, release of pathogens into the environment, and infection of people who may come into contact with animals or areas where animals are housed, or with debris from those areas. The specific biosecurity measures necessary depend on the type of operation conducted by the employer. Typically, no provision for biosecurity other than the use of common sanitation measures is required for incidental removal of animal carcasses or other wastes, unless the activity may result in the introduction of pathogens into areas where animals are kept or housed, or unless the animal is the subject of an applicable alert or disease control order