FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 1 of 20

For the most current and official copy, check QMiS.

Sections in This Document

1. Introduction................................................................................................................................. 1

2. Laboratory Safety ....................................................................................................................... 2

2.1. Hazard Evaluation and Control ....................................................................................... 3

2.1.1. Physical Hazards............................................................................................... 5

2.1.2. Chemical Hazards............................................................................................. 6

2.1.3. Biological Hazards ............................................................................................ 8

2.1.4. Radiological Hazards ........................................................................................ 9

2.1.5. Respiratory Hazards ....................................................................................... 10

2.2. General Safety Guidelines............................................................................................. 12

2.3. Emergency Response................................................................................................... 14

2.3.1. Emergency Preparedness .............................................................................. 14

2.3.2. Fire................................................................................................................... 15

2.3.3. Chemical and biological spill kits .................................................................... 15

2.4. Environmental Health (EH)............................................................................................ 15

2.5. Environmental Health & Safety Audit ............................................................................ 16

2.6. Investigations Branch Activities & Safety...................................................................... 17

2.7. ORA Environmental Health & Safety References......................................................... 17

2.7.1. FDA Staff Manual Guide ................................................................................. 17

2.7.2. National Level References.............................................................................. 17

2.7.3. Local References ............................................................................................ 17

3. Document History..................................................................................................................... 19

4. Change History......................................................................................................................... 19

5. Attachments.............................................................................................................................. 20

1. Introduction

This section provides information relating to the Environmental Health and 

Safety (EHS) of the laboratory and serves as a general overview. It also 

serves as a reference for the EHS programs developed in the laboratory. The 

laboratory's EHS documents and standard operating procedures will provide 

more detailed step-by-step instruction.

Safety is the responsibility of all Food and Drug (FDA) employees. So that 

safety has real significance in the workplace, it is actively incorporated into all 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 2 of 20

For the most current and official copy, check QMiS.

programs, procedures, and analytical methods. Each person is responsible for 

following all EHS guidelines in the course of his or her duties. Employees are 

responsible for reporting any conditions that are or may be hazardous so that 

they can be mitigated. Employees are to wear their personal protective 

equipment (PPE), use all safety equipment in the manner for which it is 

designed, report any failures of safety equipment to management, familiarize 

themselves with the hazards of all chemicals, and report any potentially unsafe 

incidents or exposures. Management establishes and funds safety programs, 

provides PPE when needed, ensures employees are trained, provides 

information about the hazards through a hazard assessment process, and 

advises employees how to control them. The agency is responsible for and 

committed to creating and maintaining a safe working environment for all 

personnel. The Industrial Hygienist will act as the Chemical Hygiene Officer in 

accordance with 29 CFR 1910.1450 to provide guidance in the development 

and implementation of the Chemical Hygiene Plan (CHP) and ensures the 

CHP is reviewed and updated as necessary.

2. Laboratory Safety

A. A safe working environment manages hazards in a manner that 

minimizes any risk to or adverse effect on the following:

1. employee health,

2. physical safety,

3. work environment, 

4. FDA property, and,

5. our neighbors.

B. 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). 

C. 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. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 3 of 20

For the most current and official copy, check QMiS.

D. Risk assessment includes the following:

1. the probability, or chance that a certain activity could result in injury, 

damage, or loss;

2. quantifies hazards by evaluating the probability of the harm being 

realized; and

3. directly correlates the exposure one has with the hazard.

E. The goal of all EHS programs is to remove as much risk as possible to 

ensure the safest work environment.

2.1. Hazard Evaluation and Control

A. Effective hazard evaluation and control methods protect workers from 

workplace hazards by minimizing potential risks providing a safer and 

healthier work environment. 

B. Controlling exposures to occupational hazards is a fundamental process 

for protecting workers in the workplace. Methods for controlling hazards 

in the workplace environment are prioritized with the industrial hygiene 

hierarchy of controls; a guiding framework to evaluate and rank hazard 

control processes. The hierarchy for controlling hazards begins with the 

most desirable option first and ends with the least desirable option as 

follows:

1. Elimination

2. Substitution

3. Engineering controls

4. Administrative controls

5. Personal protective equipment

C. The most desirable option for controlling hazards is to eliminate the 

hazard completely by physically removing the hazard from the 

workplace environment, thus preventing any potential exposure. The 

next option in the hierarchy of controls is substitution or replacing the 

hazard with something less hazardous, such as replacing a chemical 

with one less hazardous in a laboratory process. 

D. Engineering controls come next in the hierarchy and are used to isolate 

workers from the hazard by controlling the exposure using equipment 

and machinery. Examples include self-capping syringe needles, 

ventilation systems such as fume hoods, sound-dampening materials to 

reduce noise levels, safety interlocks, and radiation shielding. 

Whenever possible, Labs should select equipment and machinery that 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 4 of 20

For the most current and official copy, check QMiS.

have an inherently safer design to prevent introducing hazards into the 

workplace. 

E. Administrative controls follow engineering controls and are used to 

change the way people work in the workplace environment. Examples 

include modifications 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. 

F. The use of PPE is the least desirable way to control hazards as PPE

protects the worker by reducing exposure to the hazard; however, the 

hazard is still present. PPE only offers temporary protection with worker 

safety dependent on appropriate selection and use. therefore, it is 

critical that the proper PPE be assigned for the hazard with adequate 

training provided. PPE also has certain physical limitations in use and 

can fail or cause injury to the user if not used properly.

G. Appropriate control methods are essential to minimizing hazards in the 

laboratory, however, nothing replaces good work practices to promote a 

safe working environment. 

H. Evaluation of hazards in the workplace environment is an important 

aspect of laboratory safety. The industrial hygienist plays a critical role 

in the hazard evaluation and control process by providing support to 

supervisors and employees in analyzing the potential hazards 

associated with laboratory operations. Based on these hazard 

evaluations, safety protocols will be developed identifying the potential 

hazards and steps needed to mitigate the associated risks. Appropriate 

hazard controls should be identified in applicable laboratory safety 

documents such as the Chemical Hygiene Plan (CHP), biosafety plans, 

relevant Standard Operating Procedures (SOPs) and job instructions. 

I. Hazard evaluation includes such factors as the following:

1. Identification of health and physical hazards associated with the 

material or procedures and the ramifications of that exposure

2. Estimating the probable exposure by

a. Considering the quantity and form of material

b. Determining the distribution and degree of exposure, personnel 

exposed

3. Determining stability, compatibility, and storage issues
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 5 of 20

For the most current and official copy, check QMiS.

4. Assessing the availability and use of various controls, including PPE, 

engineering controls, and administrative controls

5. Reviewing regulatory issues such as waste or shipping issues, 

cleaning up spills, contamination control.

J. 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.

2.1.1. Physical Hazards

A. 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 29 CFR, Part 1910.

B. Potential physical hazards in the workplace include the following:

1. extreme hot and cold temperatures,

2. noise,

3. electricity,

4. sharps, and

5. electric and magnetic fields (EMF).

C. Other physical hazards include 

1. injuries from slips, trips, and falls,

2. cuts,

3. falling and other moving objects,

4. dusty environments, and

5. poor ergonomic design. 

D. In Appendix B to 29 CFR 1910.1200 -- Physical Hazard Criteria, OSHA 

defines physical hazards to mean a chemical that is the following:

1. explosive, 

2. flammable (gases, aerosols, liquids, or solids), 

3. oxidizer (liquid, solid or gas), 

4. self-reactive, 

5. pyrophoric (liquid or solid), 

6. self-heating, 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 6 of 20

For the most current and official copy, check QMiS.

7. organic peroxide, 

8. corrosive to metal, 

9. gas under pressure, or in contact with water emits flammable gas. 

E. Engineering controls physically modify a process, or process 

equipment, with the goal of preventing the release of contaminants into 

the workplace. Examples include the installation of fume hoods, 

tempering the air by heating or cooling, ensuring that Ground-FaultCircuit-Interrupter (GFCI) receptacles are in place, providing floor mats 

to reduce the chance of slipping, and separate storage for incompatible 

compounds. 

F. Physical hazards are responsible for the majority of workplace injuries 

such as improper lifting techniques, slips, trips and falls, and cuts. 

Proper housekeeping, paying attention to office and laboratory

surroundings, and other good working practices can effectively 

complement engineering controls to minimize accidents in the 

workplace.

G. 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 (2019 Edition). The NFPA covers issues with 

flammability in NFPA 30 Flammable and Combustible Liquids Code, 

and compressed gases in portable cylinders in NFPA 55. Contact your 

local IH with questions about local regulations, codes, standards or 

recommended best practices.

2.1.2. Chemical Hazards

A. Chemical hazards can enter and harm the body by four main routes:

1. Absorption through the skin;

2. Inhalation;

3. Injection; and

4. Ingestion.

B. Chemical hazards can cause harm in the many ways:

1. Fire and/or smoke;

2. Explosion or violent reaction;

3. Corrosion to equipment or facilities;

4. Chemical burns or skin/eye irritation;
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 7 of 20

For the most current and official copy, check QMiS.

5. Causing chronic organ damage over time;

6. Causing an allergic reaction; and

7. Causing genetic or reproductive harm.

C. 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 

effects of exposure not only depend on the chemical, its concentration, 

route of entry, and duration of exposure, but may also be influenced by 

personal factors such as the individual’s smoking habits, alcohol 

consumption, medication use, nutrition, age, and sex.

D. 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 timeweighted 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 in 29 CFR 1910.1000.

E. One of the easiest ways to gather information about the chemical 

hazards of a compound is to read the Safety Data Sheet (SDS)

(formerly MSDSs or Material Safety Data Sheets). No employer may 

allow the use, handling, or storage of a hazardous product in a 

workplace unless the product carries a label, a safety data sheet, and 

the worker has received the training and information to carry out the 

work entrusted to him safely. The SDSs are required to be presented in 

a consistent user-friendly, 16-section format in accordance with 29 CFR 

1910.1200. Every laboratory is required to have a SDS library 

containing an SDS sheet for every chemical in their inventory. 

Additionally, the SDSs are readily found on the websites of most of our 

suppliers. 

Examples include the following:
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 8 of 20

For the most current and official copy, check QMiS.

http://www.vwrsp.com

http://www.fishersci.com

http://hazard.com/msds/ , and

http://www.ilpi.com/msds/index.html.

F. Contact your IH or supervisor to find the location for MSDS's in your 

laboratory and how to use them.

G. In addition to general safety standards, OSHA has standards for 

chemicals in various sections of 29 CFR 1910.1; these include 

formaldehyde, benzene, benzidene, arsenic, lead, cadmium and 

methylene chloride. 

2.1.3. Biological Hazards

A. 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. 

B. 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). 

C. The following references offer guidance on the prevention of harm from 

biological agents:

1. 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)

2. U.S. Department Health and Human Services, Center of Disease 

Control, National Institute of Public Health (2002). Primary 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 9 of 20

For the most current and official copy, check QMiS.

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

3. http://www.absa.org/resources

4. http://www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm

D. 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. 

E. 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. 

F. The BMBL provides information on good work practices, proper PPE, 

safety equipment, laboratory facility design for each Biosafety Level.

G. Some biological hazards can be mitigated using 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. 

2.1.4. Radiological Hazards

A. ORA laboratories have limited use of radiological materials. The most 

common uses of ionizing radiation are sealed Nickel-63(Ni-63) 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 10 of 20

For the most current and official copy, check QMiS.

detectors in instruments such as gas chromatographs, and x-rays in 

instruments such as XRFs and XRDs. Radiation sources within these 

instruments are 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. The procedures for this are described in ORA’s 

Radiation Safety Manual.

B. Two ORA laboratories actively work with radiolabeled tritium (H-3) for 

shellfish toxin research.

C. Every Laboratory with radioactive materials falls under ORA’s Radiation 

Safety Program. Labs using tritium or other unsealed radioisotopes are 

covered by ORA’s Nuclear Regulatory Commission (NRC) site license. 

Anyone who may be exposed to external doses of ionizing radiation 

must use dosimeter badges to record any exposures. Training is 

provided annually. Other requirements are expressed in ORA’s NRC 

license and Radiation Safety Manual.

D. Contact your lab’s industrial hygienist for more information about 

radiological hazards. ORA IHs work closely with ORA’s Radiation 

Safety Officer to implement programs at their assigned labs. Any new 

program involving radiation should be coordinated through ORA’s RSO 

to ensure the work is permitted on the license. 

2.1.5. Respiratory Hazards

A. There are various types of respiratory hazards in the laboratory.

Examples of potential respiratory hazards include, but are not limited to:

1. Oxygen-deficient air

2. Particulate contaminants

3. Gas and vapor phase contaminants 

B. Particulate, gas, and vapor contaminants are the most probable 

respiratory hazard in the laboratory. When a respiratory hazard is 

identified, several methods may be used to reduce exposure. The 

preferred way of managing these hazards is through engineering 

controls or capture devices, as these will remove or mitigate the hazard. 

C. The ORA laboratories use some of the following engineering controls:

1. Directional airflow between rooms and corridors

2. Frequent air exchanges within rooms
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 11 of 20

For the most current and official copy, check QMiS.

3. Chemical hoods

4. Biosafety cabinets

5. Weighing hoods 

D. Fume hoods and other engineering controls should be used 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: 

1. Place the sash down low enough to protect the face and neck;

2. Always work at least six inches inside of the hood;

3. Never block the rear air vents;

4. Keep the amount of materials used in the hood at a minimum; and

5. Dissuade fellow employees from disturbing the air patterns when the 

hood is in use.

E. Engineering controls and capture devices should be tested and certified 

annually to ensure proper functioning and adequate performance.

F. Other ways to mitigate respiratory hazards include the following:

1. Use of vacuum systems near dust producing operations,

2. Higher number of air exchanges in laboratories than in normal office 

settings, and

3. Non-recycled laboratory air through office portions of the building

G. Some circumstances may warrant the use of respirators. 

1. 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 low. 

2. An employee might want additional protection even though the 

respiratory hazard has been mitigated to levels considered safe by 

OSHA or other governing bodies. 

3. Any use of respirators requires the laboratory to develop a 

Respiratory Protection Program as defined by 29 CFR 1910.134. 

The Industrial Hygienist is typically designated as the Respiratory 

Program Administrator for their respective laboratory for 

implementation of the program. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 12 of 20

For the most current and official copy, check QMiS.

4. Prior to wearing a respirator, the employee must be medically 

cleared to wear a respirator, trained about the hazard, instructed 

how to use a respirator, and fit-tested. 

5. The Respiratory Program Administrator will provide assistance to 

ensure the employee is assigned a respirator designed to control the 

particular potential exposure. 

6. Respirators are commonly used in the laboratory for dust control in 

grinding operations 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 Respiratory Program 

Administrator for more information on respiratory hazards and their 

mitigation.

2.2. General Safety Guidelines

A. The “Laboratory Standard,” 29 CFR 1910.1450, requires laboratories to 

develop a Chemical Hygiene Plan to protect laboratory worker from 

harm due to hazardous chemicals. The Industrial Hygienist is 

responsible for implementing the plan and is designated as the 

Chemical Hygiene Officer (CHO). Procedures for safe laboratory work 

are listed in your laboratory’s Chemical Hygiene Plan.

B. General safety guidelines include, but are not limited to the following:

1. Never work alone in the laboratory

2. Never mouth-pipette, or use mouth to start a siphon

3. Wear eye protection inthe laboratory at all times, including over

contact lenses. Prescription glasses do not qualify as laboratory eye

protection when worn alone.

4. Never sniff any chemicals

5. Practice personal hygiene rules, (e.g. always wash hands before 

leaving the laboratory)

6. No eating, drinking, applying cosmetics, or chewing gum in the 

laboratory

7. Never bring or store personal consumable products in the laboratory

8. Do not wear laboratory coats outside the laboratory area
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 13 of 20

For the most current and official copy, check QMiS.

9. Review all chemical safety information mentioned in the Safety Data 

Sheets (SDS), prior to use or transport of any chemical.

10.Know the location and proper use of emergency equipment including 

eye wash, fire alarm and safety showers

11.Be aware and follow the appropriate emergency procedures: 

including evacuation routes, spill clean-up procedures and proper 

waste disposal 

12.Personal protective equipment (PPE), follow proper personal 

hygiene practices and use appropriate PPE

a. Wear protective lab coat 

b. Wear closed toe, sturdy shoes and full-length garments

c. Inspect all protective equipment prior to use and discard 

defective equipment

d. Use hearing protection when appropriate

e. Wear appropriate hand protection based on the chemicals and/or 

task

f. Use appropriate eye and face protection (e.g. safety glasses, 

goggles, face shield)

13.Practice good housekeeping techniques

a. Keep walkways and path of egress clear

b. Ensure all eye wash stations, emergency showers, fire 

extinguishers, and exits are always unobstructed and accessible

c. Properly label containers

d. Store hazardous chemical in appropriate cabinets

e. Use proper methods of transporting chemicals within the facility

f. Promptly clean up all spills in the laboratory. See Spills handling 

procedures for your laboratory for details

g. Keep work areas clean and tidy

14.Follow proper waste disposal procedures:

15.Consult the Chemical Hygiene Plan and the CHO for additional 

laboratory specific safety guidance. 

C. Accident reporting:

1. Immediately report all accidents and complete the appropriate forms 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 14 of 20

For the most current and official copy, check QMiS.

D. Fire Safety

1. Call emergency or security, pull/sound the fire alarm, and 

immediately evacuate the building 

2.3. Emergency Response

While accidents or serious mishaps in the laboratory are rare, it is extremely 

important to be prepared and know what to do in case of an emergency. 

Laboratories are outfitted with specialized equipment and kits for chemical 

spills, fires, and personal injuries. Written procedures specifying what one 

should do in emergencies are available. Refer to your local Occupant 

Emergency Plan (OEP) for specific site information on responding to 

emergencies in your lab.

2.3.1. Emergency Preparedness

A. Know laboratory policies and procedures. 

B. Read the laboratory’s Chemical Hygiene Plan and Occupant 

Emergency Plan to determine the steps needed in different 

emergencies. The emergency response plan and occupant emergency 

plan can provide useful information. These documents provide the 

following information: who to contact in an emergency, when and how to 

clean up a chemical spill, where the Safety Data Sheets (SDSs) are 

located, and when one should use a fire extinguisher. If clarification is 

needed on any of these or other emergency procedures, ask a 

supervisor or the Industrial Hygienist.

C. Be familiar with laboratory surroundings. From the laboratory bench, 

know where the nearest exit(s), eyewash fountain, safety shower, 

MSDS, fire extinguisher, and first aid kit are located. It is a good 

practice to identify two exits in case one is inaccessible. Before working 

in a different location, identify the location all safety equipment. If 

anyone cannot locate any of the above-mentioned items, ask the 

Industrial Hygienist, a supervisor or a co-worker for assistance. 

D. Practice. The best way to understand something thoroughly is to run 

through a mock exercise or drill. Consider instances where one may 

need to walk from a hood to the eyewash station if one’s eyesight is 

impaired due to acid splashed in the eye. Know how to activate the 

eyewash as well as the length of time required to apply the water rinse. 

This exercise can also be applied an accident that would need the use 

of safety showers. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 15 of 20

For the most current and official copy, check QMiS.

2.3.2. Fire

A. Be aware of the nearest fire exits. In the event of a fire, alert others to 

the situation. 

B. Trained, authorized personnel only use fire extinguishers, provided in 

the laboratory. Use of a fire extinguisher is voluntary, and should only 

be used if the fire can be contained safely otherwise evacuate 

immediately. 

C. If someone is injured, assess the situation; assist if possible. 

D. Immediately leave the area, close the doors, and leave by the nearest 

exit. Refer to your Occupant Emergency Plan for guidance on contact 

information. Follow the laboratory’s evacuation plan. Follow any special 

procedures in the laboratory’s evacuation plan (e.g. some facilities 

arrange for supervisors to meet with their group outside to account for 

any potential missing employees). 

E. Fire drills should be held at least annually.

2.3.3. Chemical and biological spill kits

Be familiar with chemical and biological spill kits contents and their procedures 

for cleaning up spills. Be familiar with your labs spill clean-up procedures 

located in your lab’s chemical hygiene plan and biosafety manual. If you have 

any questions, contact the Industrial Hygienist.

2.4. Environmental Health (EH)

A. Executive Order 13148, Greening the Government through Leadership 

in Environmental Management, requires federal agencies to develop 

environmental programs, policies, and procedures to ensure 

compliance with federal law.

B. The FDA Office of Laboratory Safety and Science (OLSS) schedules 

Environmental Audits periodically depending on laboratory size. 

Smaller ORA laboratories will be audited every five years while larger 

laboratories will be audited every three years. These audits will assure 

labs are complying with both federal and state regulations.

C. ORA laboratories can ensure they comply with environmental 

regulations by keeping abreast with changes in environmental 

regulations, performing inspections as needed, recording these 

inspections and maintaining proper records. These records include, but 

not limited to, the following: TSDF signed hazardous waste manifests, 

central waste accumulation inspection forms and having permits (air, 

water) available. Other areas to consider are complete training records 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 16 of 20

For the most current and official copy, check QMiS.

and proper documented review of laboratory Chemical Hygiene and 

Respirator Program Plans.

D. The Immediate Office - Office of Business and Safety Operations (IOOBSO) has developed an environmental audit tool which assists 

laboratories in organizing their programs. The tool encourages 

laboratories to create one location or binder for all required 

environmental information for their site. Contact your lab’s industrial 

hygienist for more information about environmental programs or the 

audit tool. 

2.5. Environmental Health & Safety Audit

A. Laboratories in ORA are inspected under the Administrative Quality 

Assurance Plan program (AQAP). Items that are inspected and 

evaluated during this inspection may include: 

1. Environmental (e.g. temperature, lighting, noise, tripping hazards, 

stable shelving, and odors); 

2. Housekeeping (e.g. neat storage areas, clear aisles, safe storage, 

trash disposal); 

3. Fire safety (e.g. emergency evacuation plan, emergency lights, 

clearance of combustibles from open flames and hot equipment);

4. Electrical (e.g. switch cover plates used, no power cord frays, 

permanent wiring used, GFCI used in wet areas, circuit breakers 

identified);

5. General laboratory safety (e.g. no food or drink in the laboratory, 

proper storage of chemicals, proper facility for solvent storage, no 

excess chemicals, certified hoods and Biosafety Cabinets, proper 

use of hoods, labels on chemicals and refrigerators, hazard signage 

on laboratory doors, proper management of carcinogens, peroxide 

labels used, no mercury contamination, pipetting devices used, 

equipment is grounded, equipment operated under pressure 

inspected, glass under pressure taped) ;

6. Compressed Gas Safety (e.g. gas cylinders are labeled, secured, 

properly transported, and properly stored, correct regulators used);

7. Protective Equipment (e.g. laboratory coats, safety glasses, goggles, 

face shields, gloves, closed toe shoes, respirators, flushed 

eyewashes and safety showers, maintained first aid kits)

8. Radiation Safety (e.g. radiation safety plan and radiation safety 

officer, proper signage, spill kits, film badges used); and 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 17 of 20

For the most current and official copy, check QMiS.

9. Waste management, including infectious, hazardous, select agent, 

radioactive, recycled, and universal wastes(e.g. regulated wastes 

properly managed, labeled, proper disposition and documentation)

2.6. Investigations Branch Activities & Safety

Analysts may be involved with activities traditionally associated with the 

Investigations Branch. These duties include, but are not limited to 

investigations, wharf exams, inspections, sample collections, and recall 

checks. The exposure the analysts receive related to these duties may be 

different from those found in the laboratory. Prior to starting the assignment, 

review the duties and the expected hazards with the supervisor, Industrial 

Hygienist, or the lead investigator. Refer to the 'Investigations Operations 

Manual’ (IOM) for further safety guidance related to these duties. A copy of the 

IOM can be viewed by contacting the local Investigations Branch or on-line at: 

http://www.fda.gov/ICECI/Inspections/IOM/default.htm

2.7. ORA Environmental Health & Safety References

2.7.1. FDA Staff Manual Guide

ORA's EHS policies reside in the FDA Staff Manual Guide 2130.1. The Staff 

Manual Guide sets forth the Food and Drug Administration's authority, policy, 

scope, and assignment of responsibility towards the establishment and 

management of a comprehensive safety and occupational health program. The 

link to the Staff Manual Guide is: 

http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/defa

ult.htm

2.7.2. National Level References

The following references are promulgated at the National level. They provide 

general safety information:

1. The NTEU Collective Bargaining Agreement, Article 50: Health and 

Safety

2. FDA Intranet Safety web site:

https://intranet.hhs.gov/manual/consolidated-collective-bargainingagreement

2.7.3. Local References

The Chemical Hygiene Program describes your laboratories specific policies, 

procedures, equipment, personal protective equipment and work practices that 

protect lab staff from health hazards presented hazardous chemicals used in 

your laboratory. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 18 of 20

For the most current and official copy, check QMiS.

The Hazardous Waste Program is written specifically for your laboratory and 

needs to comply with all federal and state environmental regulations. 

Laboratory waste amounts determine if your facility is considered a very small, 

small or large quantity generator of hazardous waste. Laboratories will need 

to keep monthly waste generation logs to determine which category they 

belong. 

The following plans are also required and are written as sit-specific: evacuation 

and occupant emergency plan, as well as the BioSafety Manual:

2.7.3.1. Radiation Safety Program

A. All field laboratories that have radioactive sources on-site have this 

program. Sources of radiation typically found in ORA field laboratories 

include tritium, used in shellfish toxin research, and Nickel-63, used in 

some laboratory instruments.

B. Regulations regarding radiological hazards in the work place include:

1. 10CFR19: Notices, instructions, reports to workers, inspections.

2. 10CFR20: Standards for protection against radiation.

3. 10CFR21: Reporting of defects and non-compliance.

4. 10CFR71: Packaging and transportation of radioactive materials

5. NRC Reg Guide 8.36: Radiation Dose to Embryo/Fetus.

2.7.3.2. Department of Transportation (DOT) Shipment of Dangerous 

Goods

As mandated by DOT, the shipment of microbiological slants and hazardous 

chemicals requires detailed packaging and labeling. The laboratory may have 

a work instruction or standard procedure devoted to these requirements.

2.7.3.3. Bloodborne Pathogens Program

Although few FDA Field laboratories require this program, the bloodborne 

pathogens program is followed when the laboratory analyzes products that 

have been inside a human body, (e.g. ex-planted medical devices or pills that 

were ingested then expelled, or been in contact with bodily fluids such as 

blood, saliva, or vomitus), pharmaceuticals that may contain constituents 

derived from blood products, or sample analyses that use blood products in 

their analyses (e.g. invitro-diagnostics). Analysts receive bloodborne pathogen 

training and are able to handle these samples safely prior to analyzing 

samples in this program area. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 19 of 20

For the most current and official copy, check QMiS.

2.7.3.4. Institutional Animal Care and Use Committee (IACUC) and 

Association for Assessment and Accreditation of Laboratory 

Animal Care (AAALAC) Program

Few FDA laboratories have this program. Only those FDA AAALAC 

laboratories with IACUC approved protocols may perform animal testing. 

2.7.3.5. Select Agent Program

Any ORA laboratory working with select agents regulated by CDC should have 

this program in place. The laboratory must be registered with CDC to transfer 

any select agents listed in their regulations in 42 CFR 72.6. CDC inspects 

facilities to ensure the facilities are capable of handling these organisms. All 

receipts, transfers, and disposals of agents are documented on their EA101 

form.

3. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.3 R 02/06/2012 LMEB LMEB

1.4 R 01/29/2013 LMEB LMEB

02 R 08/13/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

4. Change History

Revision 

# Change

1.3

1.1.1 – section deleted

1.2.1 – added administrative and engineering controls definition to fourth paragraph

1.2.1.1 – added OSHA 29CFR, Part 1910

1.6 – updated IOM weblink

1.7.1 – updated SMB weblink

1.7.2 – updated NTEU CBA weblink

1.7.3 – updated IOM reference and weblink

1.8 – added section

1.4 Header – Division of Field Science changed to Office of Regulatory Science

1.5 Deleted References

02 Extensive content revisions made by the ORS Safety staff. Formatting was also 

revised to improve layout of the document.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 1

Document Number:

III-01

Revision #: 02

Revision Date:

08/13/2019

Title: 

Environmental Health and Safety Page 20 of 20

For the most current and official copy, check QMiS.

5. Attachments

None