Food and Drug Administration
VERSION NO.: 1.4
A safe working environment manages hazards in a manner that minimizes any risk to or adverse effect on the following:
- employee health,
- physical safety,
- work environment,
- FDA property, and,
- our neighbors.
ORA facilities strive to offer a safe working environment for all employees. Management strives to comply with all regulatory requirements under Federal, State, and local agencies that oversee laboratory operations. This includes the Environmental Protection Agency (EPA), the Occupational Safety and Health Agency (OSHA), the Department of Transportation (DOT), the Nuclear Regulatory Commission (NRC), the Center for Disease Control and Prevention (CDC), and the Drug Enforcement Agency (DEA).
Many of the samples tested in the laboratory are highly regulated commodities that may contain deleterious contamination. Safety hazards include harmful chemicals or disease producing agents, and are acts or phenomena that have the potential to produce immediate physical or health harm, or other undesirable effect to some person or thing.
Risk assessment includes the following:
- the probability, or chance that a certain activity could result in injury, damage, or loss,
- quantifies hazards by evaluating the probability of the harm being realized, and
- directly correlates the exposure one has with the hazard.
The goal of all EHS programs is to remove as much risk as possible to ensure the safest work environment.
Hazard control and hazard evaluation provides a safe working environment.
The three basic procedures to control hazards are the following:
- administrative controls,
- engineering controls, and,
- personal protective equipment.
However, nothing replaces good work practices for ensuring the safest work environment possible.
Administrative controls are changes in work procedures such as written safety policies, rules, supervision, schedules, and training with the goal of reducing the duration, frequency, and severity of exposure to hazardous chemicals or situations. Engineering controls eliminate or reduce exposure to a chemical or physical hazard through the use or substitution of engineered machinery or equipment. Examples include self-capping syringe needles, ventilation systems such as a fume hood, sound-dampening materials to reduces noise levels, safety interlocks, and radiation shielding. Administrative and engineering controls are the preferred method of hazard mitigation as they reduce or remove the hazards, and provide protection in the event of an error in work practices. The use of PPE is the least desirable way to control hazards. PPE only reduces exposure to the hazard; the hazard is still present. PPE can fail during use and only offer temporary protection. It is critical the proper PPE is assigned for the hazard. PPE also has certain physical limitations in use and can even cause injury to the user if not used properly.
Supervisors and employees analyze the significance of potential hazards associated with laboratory operations through risk analysis or hazard evaluation. Proactive safety protocols prepared for new projects or very hazardous methods can systematically identify the risks and plan what steps can be taken to mitigate the risks.
Hazard evaluation includes such factors as the following:
- Identification of health and physical hazards associated with the material or procedures and the ramifications of that exposure
- Estimating the probable exposure by
- Considering the quantity and form of material
- Determining the distribution and degree of exposure, personnel exposed
- Determining stability, compatibility, and storage issues
- Assessing the availability and use of various controls, including PPE, engineering controls, and administrative controls
- Reviewing regulatory issues such as waste or shipping issues, cleaning up spills, contamination control.
A risk control assessment that fully addresses these issues and evaluates any alternatives should be the basis for a systematic plan or work instruction for projects in the laboratory.
220.127.116.11 Physical Hazards
Physical hazards are those caused by direct interaction with the mechanics of the work environment. For exposure limits and recommendations by the Occupational Health and Safety Administration (OSHA), see 20 CFR, Part 1910.
Potential physical hazards in the workplace include the following:
- extreme hot and cold temperatures,
- sharps, and
- electric and magnetic fields (EMF).
Other physical hazards include
- injuries from slips, trips, and falls,
- falling and other moving objects,
- dusty environments, and
- poor ergonomic work practices.
In the Laboratory Standard, OSHA defines physical hazards to mean a chemical that is the following:
- combustible liquid,
- compressed gas,
- organic peroxide,
- unstable (reactive), or
- water reactive.
Engineering controls, meaning the source of the hazard is modified by a permanent solution, mitigate most physical hazards. Examples include the installation of fume hoods, tempering the air by heating or cooling, ensuring that Ground-Fault-Circuit-Interrupter (GFCI) receptacles are in place, providing floor mats to reduce the chance of slipping, and separate storage for incompatible compounds.
Physical hazards are the number one cause of laboratory accidents. Improper lifting techniques, slips, trips and falls, and cuts make up the vast majority of laboratory accidents. Proper housekeeping, paying attention to office and laboratory surroundings, and other good working practices can minimize all of these accidents.
OSHA addresses some of the physical hazard issues in the general sections in 29 CFR 1910. The National Fire Protection Agency covers laboratories in NFPA 45 Standard on Fire Protection for Laboratories Using Chemicals (2000 Edition). The NFPA covers issues with flammability in NFPA 30 Flammable and Combustible Liquids Code, and compressed gases in portable cylinders in NFPA 55.
18.104.22.168 Chemical Hazards
Chemical hazards can enter and harm the body by four main routes:
- Absorption through the skin;
- Injection; and
Chemical hazards cause harm in seven different ways:
- Catching fire;
- Explosive or reactive;
- Causing chronic organ damage over time;
- Causing an allergic reaction; and
- Causing genetic or reproductive harm.
A chemical's potential for harm is affected by its properties, (e.g. solid, liquid or gas). If it is a solid, what size are the pieces - micron sized particles, granules, or large chunks? What is the temperature of the chemical? How easily is the chemical absorbed through the skin? Is it toxic? Does it persist in the environment, or is it easily dissipated?
The hazardous properties of many of the chemicals used in the laboratory have been extensively studied by the National Toxicology Program (NTP), the International Agency for Research on Cancer Monographs (IARC), and the American Conference of Government Industrial Hygienists (ACGIH). ACGIH has established Threshold Limit Values, or TLVs, for many chemicals. The TLV is an 8-hour time-weighted average (TWA) believed to be the average concentration most workers can be exposed during an 8-hour workday, day after day, five days per week, without harmful effects. Short-term exposure limits (STEL) establishes for materials that are more toxic the maximum concentration employees can be exposed for periods up to fifteen minutes that should not be exceeded at any time during a workday. Ceiling (C) is a maximum concentration never to be exceeded. OSHA adapted many of the recommendations of the ACGIH and listed the chemicals and their permissible exposure limits for the TWA in the Limits for Air Contaminants Table (Table Z-1) in 29 CFR 1910.1000.
One of the easiest ways to gather information about the chemical hazards of a compound is to read the Material Safety Data Sheet (MSDS). No employer may allow the use, handling, or storage of a controlled hazardous product in a workplace unless the product carries a label, a material safety data sheet, and the worker has received the training and information to carry out the work entrusted to him safely. Every laboratory is required to have a MSDS library containing an MSDS sheet for every chemical in their inventory. Additionally the MSDSs are readily found on the websites of most of our suppliers.
Examples include the following:
- http://hazard.com/msds/ , and
Contact your Chemical Hygiene Officer or supervisor to find the location for MSDS's in your laboratory and how to use them.
In addition to general safety guidelines, OSHA has standards for chemicals in various sections of 29 CFR 1910.1; these include formaldehyde, benzene, benzidene, arsenic, lead, cadmium and methylene chloride.
22.214.171.124 Biological Hazards
Biological hazards are biological agents and materials that can adversely affect humans, animals, and plants. Biohazards include infectious or etiologic agents, certain toxins and other biological material, bacteria, fungi, viruses, parasites, prions, Rickettsiae, recombinant products, allergens, arboviruses. Primary laboratory vectors for these hazards include decomposed foods, foods contaminated with insects, rodents, fecal material and other raw or unclean foods. In rare cases, your laboratory may accept samples that may carry blood-borne pathogens.
A biosafety program should be established for those laboratories performing microbiological work; there also may be some biosafety information in the laboratory's Chemical Hygiene Program (CHP). A Blood-borne pathogen program should be established for those laboratories working with blood borne pathogens. Information on the Blood-borne Pathogen program can be found in 29 CFR 1910.1030. All FDA laboratories working with animals must coordinate their analytical, training and research procedures involving animals through the FDA/ORA Institutional Animal Care and Use Committee (IACUC).
The following references offer guidance on the prevention of harm from biological agents.
- U.S. Department Health and Human Services, Center of Disease Control, National Institute of Public Health. (1999). Biosafety in Microbiological and Biomedical Laboratories. (Stock no 017-040-00547). U.S. Government Printing Office. (BMBL)
- U.S. Department Health and Human Services, Center of Disease Control, National Institute of Public Health (2002). Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets , Second Edition, U.S. Government Printing Office., reference for ordering found on the website: http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm
Containment is the key consideration when working with biohazards. Class II Biosafety Cabinets are designed to protect both the user and the product through ventilation control. Laminar Flow Cabinets are dissuaded in most laboratories because there is no protection for the user. However, laminar flow hoods may be used for non-biohazard situations such as sterility testing and drying agar plates.
The BMBL classifies most of the biohazardous viable organisms into four biosafety levels with Biosafety Level 1 (BSL-1) assigned to those organisms not known to consistently cause disease in healthy adults. Some caution should be used when handling these organisms because they can cause problems for immuno-compromised individuals. BSL-2 organisms represent moderate risk to people and are associated with human disease of varying severity; most of the organisms handled in ORA laboratories are BSL-2. BSL-3 organisms are very difficult to contain and transmit serious or lethal infections; ORA has very limited work presently with BSL-3 organisms. BSL-4 agents pose a high individual risk of life threatening disease; special practices, safety equipment, facility design, and construction are needed when working with these organisms. ORA is not performing any work with BSL-4 organisms.
The BMBL provides information on good work practices, proper PPE, safety equipment, laboratory facility design for each Biosafety Level.
Some biological hazards can be mitigated by the use of vaccines. ORA will provide vaccinations for laboratory personnel for the following biological agents: hepatitis A, hepatitis B vaccination series, anthrax, rabies, tetanus, influenza, . Contact the CHO or supervisor for more information. Vaccinations are presently voluntary and may cause untoward reactions in people. A risk assessment is performed with any biohazardous project to assess the need for mandatory vaccinations.
126.96.36.199 Radiological Hazards
ORA laboratories have limited use of radiological materials. The most common use of ionizing radiation is the sealed Nickel-63(Ni-63) detector in gas chromatographs. This radiological source is heavily shielded. Biannual swipes, required for all Ni-63 detectors to ensure there is no leakage of radioactive material, are forwarded to Winchester Engineering and Analytical Center (WEAC) for analysis. Records of their swipe history are maintained where the detector are located.
Several ORA laboratories actively work with radiolabeled Phosphorous-32 (P-32) for microbiological probe work, and tritium in the Charm procedure in the analysis of chloramphenicol.
Every Laboratory with radiological sources has a Radiation Safety Program and is registered with the Nuclear Regulatory Commission. Any one who may be exposed to ionizing radiation is fitted with dosimeter badges to record any exposures. Training is provided annually. Other requirements are expressed in the ORA radiation license and in 10 CFR Parts 1-199.
Contact your Radiation Safety Officer (RSO) for more information about radiological hazards. The ORA radiation program is managed through the WEAC facility. All ORA facilities are listed on the WEAC radiation license and the WEAC RSO serves as the lead radiation officer for all other facilities. Any new program involving radiation should be coordinated through WEAC to ensure the work is permitted on the license.
188.8.131.52 Respiratory Hazards
There are three types of respiratory hazards:
- Oxygen-deficient air;
- Particulate contaminants; and
- Gas and vapor contaminants.
In the laboratory, particulate, gas, and vapor contaminants are the most probable. The most preferred way of dealing with these hazards is through engineering controls, as these will remove or mitigate the hazard. The ORA laboratories use the following ventilation controls:
- Use of directional airflow in the rooms;
- Frequent air exchanges in the rooms;
- Use of chemical hoods;
- Biosafety cabinets; and
- Weighing hoods
Use the hood often to mitigate respiratory hazards. This ubiquitous source of protection is one of the best defenses in the laboratory. The analyst should use the following procedures when working in the hood:
- Place the sash down low enough to protect the face and neck;
- Always work at least six inches inside of the hood;
- Never block the rear air vents;
- Keep the amount of materials used in the hood at a minimum; and
- Dissuade fellow employees from disturbing the air patterns when the hood is in use.
Hoods are certified annually.
Other ways to mitigate respiratory hazards include the following:
- use of vacuum systems near dust producing operations,
- higher number of air exchanges in laboratories than in normal office settings, and
- non recycled laboratory air through office portions of the building.
The following cases may warrant the use of respirators. Laboratory exposure to respiratory hazards may not be controlled using the usual ventilation devices in instances where the TLV or PEL level for safe exposure is very small. An employee may want additional protection even though the respiratory hazard has been mitigated to levels considered safe by OSHA or other governing bodies. Any use of a respirator requires that the laboratory have a Respiratory Protection Program as defined by 29 CFR 1910.134. Care is taken to assign the employee a respirator designed to control his particular potential exposure. Under the OSHA Respiratory program, the employee must be medically fit to wear a respirator, trained about the hazard, instructed how to use a respirator, and fit-tested.
Respirators are commonly used in the laboratory for dust control in grinding operations. Typical respirators use P100 filters. Those involved with hazardous waste consolidation may be fitted with half mask respirators and organic acid vapor cartridges. Some analysts involved with counterterrorism activities may also be fitted with half-mask respirators with P100 or and Defender cartridges. Consult your Respiratory Protection Program and CHO for more information on respiratory hazards and their mitigation.
The "Laboratory Standard," 29 CFR 1910.1450, requires a Chemical Hygiene Program and designated Chemical Hygiene Officer. The basic tenets of safe laboratory work will be found in your local Chemical Hygiene Program.
General safety guidelines and rules include, but are not limited to the following:
- Never work alone in the laboratory
- Never mouth-pipette
- Wear safety glasses or goggles at all times in the laboratory
- Practice personal hygiene rules, (e.g. wash hands before leaving the laboratory)
- No eating or drinking in the laboratory
- Use personal protective equipment (PPE)
- Do not wear laboratory coats outside the laboratory area
- Wear closed toe, sturdy shoes
- Practice good housekeeping techniques
- Keep walkways clear
- Label and date all containers
See the Chemical Hygiene Plan for guidance identified for the local laboratory.