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Revision #: 02
OFFICE OF REGULATORY AFFAIRS III-01
Revision Date:
ORA Laboratory Manual Volume III Section 1 08/13/2019
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Environmental Health and Safety
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
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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-Fault-
Circuit-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;
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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
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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.
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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.
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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
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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.
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3. Document History
Revision Status* Approving Official Name
Date Author Name and Title
# (D, I, R) and Title
4. Change History
Revision
Change
#
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
1.3
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
Extensive content revisions made by the ORS Safety staff. Formatting was also
02
revised to improve layout of the document.
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5. Attachments
None