INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER S

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CHAPTER S - SAFETY

S.1 - PURPOSE .......................................................................................................................................... 6

S.2 - UNACCEPTABLE RISK ........................................................................................................................ 6

S.2.1 - C.O.V.E.R. (CONTROL, OBSERVE, VARY, EXIT, REPORT) ..........................................................................7

S.2.1.1 - CONTROL............................................................................................................................................7

S.2.1.2 - OBSERVE ............................................................................................................................................7

S.2.1.3 - VARY..................................................................................................................................................7

S.2.1.4 - EXIT ...................................................................................................................................................7

S.2.1.5 - REPORT ..............................................................................................................................................8

S.3 - PERSONAL SAFETY ............................................................................................................................ 8

S.3.1 - UNIFORM USE..............................................................................................................................9

S.3.2 - PERSONAL SAFETY ALERTS (PSA).....................................................................................................10

S.3.2.1 - STEPS TO CREATING A PSA...................................................................................................................11

S.3.3 - PERSONAL SAFETY TRAINING ..........................................................................................................11

S.3.3.1 - MP118 INTERVIEWING SKILLS AND PERSONAL SAFETY REPORTS.................................................................11

S.3.3.2 - MP8001S: ORA PERSONAL SAFETY AND INSPECTIONS REFRESHER 8 PART TRAINING SERIES..........................11

S.4 - EMPLOYER/EMPLOYEE SAFETY RESPONSIBILITIES ........................................................................... 12

S.4.1 - SAFETY INCIDENT REPORTING .........................................................................................................12

S.5 - FOLLOWING FIRM SAFETY REQUIREMENTS .................................................................................... 13

S.6 – SAFETY RISK ASSESSMENT FRAMEWORKS ...................................................................................... 14

S.7 - ADDITIONAL SAFETY INFORMATION ............................................................................................... 14

S.7.1 - FDA/ORA SAFETY PROGRAMS .......................................................................................................14

S.7.1.1 - FDA ORA SAFETY PROGRAM ...............................................................................................................14

S.7.1.1.1 - Industrial Hygiene (IH) Contact List.............................................................................................15

S.7.1.1.2 - ORA Safety Office FAQs ..............................................................................................................15

S.7.1.1.3 - ORS Safety Hazard Assessments Grab & Go's.............................................................................15

S.7.1.1.4 - Office of Security and Emergency Management (OSEM)............................................................15

S.7.1.2 - OCCUPATIONAL SAFETY AND HEALTH (OSH) PROGRAM............................................................................15

S.7.2 - EMERGENCY RESPONSE/INCIDENT COMMAND ....................................................................................15

S.7.2.1 - OFFICE OF EMERGENCY MANAGEMENT (OEM).......................................................................................16

S.7.2.2 - OFFICE OF EMERGENCY OPERATIONS (OEO)...........................................................................................16

S.7.2.3 - ADDITIONAL EMERGENCY-RELATED SITES ...............................................................................................16

S.7.3 - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)..............................................................17

S.7.3.1 - OSHA MEMORANDUM OF UNDERSTANDING (MOU) ..............................................................................17

S.7.3.2 - OSHA SEVERE VIOLATOR ENFORCEMENT PROGRAM (SVEP).....................................................................17

S.7.4 - OTHER SAFETY AGENCIES ..............................................................................................................18

S.8 - HIERARCHY OF CONTROLS .............................................................................................................. 18

S.8.1 – GENERAL PROTECTIVE AND PREVENTIVE MEASURES...........................................................................20

S.9 - PPE ................................................................................................................................................ 20

S.9.1 - EYE AND FACE ............................................................................................................................21

S.9.2 - HEAD.......................................................................................................................................21

S.9.3 - FOOT.......................................................................................................................................22

S.9.4 - GENERAL BODY ..........................................................................................................................22
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S.9.5 - HANDS.....................................................................................................................................22

S.9.6 - HEARING ..................................................................................................................................23

S.9.7 - RESPIRATORY .............................................................................................................................23

S.9.8 – MARINE/WATER/FLOTATION ........................................................................................................24

S.9.9 - COMMON PPE...........................................................................................................................25

S.9.10 - PPE ON/OFF SEQUENCE ..............................................................................................................25

S.9.11 - MAINTENANCE AND CARE OF PPE .................................................................................................26

S.9.12 - PURCHASING PROTECTIVE EQUIPMENT ............................................................................................26

S.10 - ORA SAFETY OFFICE ...................................................................................................................... 26

S.10.1 ORA SAFETY CONTACTS................................................................................................................26

S.11 - RESOURCES .................................................................................................................................. 27

S.11.1 - RESPIRATORY PROTECTION RESOURCES ...........................................................................................27

S.11.2 - QMIS ....................................................................................................................................27

S.12 - SPECIAL SAFETY SITUATIONS ........................................................................................................ 27

S.12.1 - FIRE/EXPLOSION HAZARDS...........................................................................................................27

S.12.2 - PORTABLE/PERSONAL ELECTRONIC DEVICES (PEDS) ...........................................................................30

S.12.3 - LITHIUM BATTERIES ...................................................................................................................30

S.12.4 - CONFINED SPACES.....................................................................................................................31

S.12.5 - THERMAL PROCESSING/RETORTS...................................................................................................32

S.12.6 ALTERED/OXYGEN-DEFICIENT ATMOSPHERE ENVIRONMENTS..................................................................32

S.12.6.1 - AMMONIA ......................................................................................................................................33

S.12.6.2 - FUMIGANTS AND FUMIGATION ...........................................................................................................33

S.12.6.2.1 - Fumigant Use by Regulated Firms............................................................................................35

S.12.6.2.2 - Fumigants related to Sampling.................................................................................................36

S.12.6.2.3 - Procedures for Fumigation .......................................................................................................37

S.12.6.2.4 - Exceptions to Fumigation .........................................................................................................37

S.12.6.2.5 - Preservation Liquids..................................................................................................................37

S.12.6.3 - ETHYLENE OXIDE (ETO).....................................................................................................................37

S.12.6.4 - NITROGEN ......................................................................................................................................38

S.12.6.5 - OZONE ...........................................................................................................................................39

S.12.7 - LOCKOUT/TAGOUT (LOTO).........................................................................................................39

S.12.8 – REPRODUCTIVE HAZARDS AND PREGNANT EMPLOYEES........................................................................40

S.13 - BIOLOGICAL HAZARDS .................................................................................................................. 41

S.13.1 - MICROORGANISMS ....................................................................................................................42

S.13.2 - VIRUSES..................................................................................................................................42

S.13.3 - BACTERIA................................................................................................................................42

S.13.4 - FUNGI....................................................................................................................................42

S.13.5 - PARASITES...............................................................................................................................42

S.13.6 - PRIONS...................................................................................................................................43

S.13.7 - BIOLOGICAL ALLERGENS ..............................................................................................................43

S.13.8 - BIOLOGICAL TOXINS ...................................................................................................................43

S.13.9 - ROUTES OF INFECTION/INTOXIFICATION...........................................................................................43

S.13.10 - SOURCES OF BIOLOGICAL HAZARDS ..............................................................................................44

S.13.10.1 - ANIMALS AND ANIMAL ORIGIN PRODUCTS..........................................................................................44
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S.13.10.2 - RODENT-INFESTED AREAS - HANTAVIRUS ...........................................................................................44

S.13.10.3 - POULTRY HOUSES...........................................................................................................................45

S.13.10.4 - ANIMAL FEED ................................................................................................................................45

S.13.10.5 - SUB-HUMAN PRIMATE AND ANIMAL TESTING FACILITY HAZARDS............................................................45

S.13.10.6 - PLANTS AND PLANT PRODUCTS.........................................................................................................46

S.13.10.6.1 - Psyllium...................................................................................................................................46

S.13.10.7 – HUMAN BIOLOGICS (BLOOD, TISSUE, PLASMA AND OTHER BODILY FLUIDS).............................................46

S.13.10.8 - BIOHAZARDOUS WASTE...................................................................................................................46

S.13.10.9 - PROCESSING FACILITIES ...................................................................................................................46

S.13.10.9.1 - Precautions - Blood and Plasma Inspections...........................................................................47

S.14 - CHEMICAL HAZARDS .................................................................................................................... 48

S.14.1 - CHEMICAL HAZARD BASICS ..........................................................................................................49

S.14.1.1 - ROUTES OF ENTRY FOR CHEMICAL HAZARDS ..........................................................................................49

S.14.1.1.1 - Inhalation .................................................................................................................................49

S.14.1.1.2 - Skin Absorption.........................................................................................................................49

S.14.1.1.3 Ingestion .....................................................................................................................................49

S.14.2 CHEMICAL HEALTH HAZARDS .........................................................................................................49

S.14.2.1 – TOXICITY ........................................................................................................................................50

S.14.2.2 - CORROSIVES / IRRITANTS (SKIN, EYE, RESPIRATORY)...............................................................................50

S.14.2.3 - SENSITIZATION (SKIN, RESPIRATORY)....................................................................................................51

S.14.2.4 - GERM CELL MUTAGENICITY ...............................................................................................................51

S.14.2.5 - CARCINOGENICITY ............................................................................................................................51

S.14.2.6 - ASPIRATION HAZARDS .......................................................................................................................51

S.14.2.7 - SIMPLE ASPHYXIANTS........................................................................................................................51

S.14.3 - CHEMICAL PHYSICAL HAZARDS ......................................................................................................52

S.14.3.1 - CORROSIVE TO METALS .....................................................................................................................52

S.14.3.2 - EXPLOSIVES .....................................................................................................................................52

S.14.3.3 - FLAMMABLES AND COMBUSTIBLES ......................................................................................................52

S.14.3.4 - SELF-REACTIVE CHEMICALS ................................................................................................................53

S.14.3.5 - PYROPHORIC (LIQUIDS OR SOLIDS).......................................................................................................53

S.14.3.6 - SELF-HEATING SUBSTANCES................................................................................................................53

S.14.3.7 - WATER-REACTIVE MATERIALS .............................................................................................................53

S.14.3.8 - OXIDIZERS (LIQUID, SOLID OR GAS) ......................................................................................................53

S.14.3.9 - GASES UNDER PRESSURE ...................................................................................................................54

S.14.3.10 - ORGANIC PEROXIDES ......................................................................................................................54

S.14.4 - ADDITIONAL CHEMICAL HAZARD INFORMATION/RESOURCES.................................................................54

S.14.4.1 - CHEMICAL LABELING.........................................................................................................................55

S.14.4.1.1 - Resources related to Hazard Communication (HAZCOM)/chemical labeling............................58

S.14.5 – SPECIAL CHEMICAL HAZARDS .......................................................................................................58

S.14.5.1 - ALLERGENS/HYPERSENSITIVITIES .........................................................................................................58

S.14.5.2 - ANIMAL FOOD INGREDIENTS ..............................................................................................................58

S.14.5.3 - DRY ICE- TRANSPORT AND USE FOR SHIPPING SAMPLES ..........................................................................59

S.14.5.4 - OPIOIDS .........................................................................................................................................60

S.15 - PHYSICAL AND RADIATION HAZARDS ............................................................................................ 60
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S.15.1 - TRAUMATIC INJURY HAZARDS/INDUSTRIAL INJURIES AND ENERGY RELATED ILLNESSES ..................................60

S.15.1.1 - GENERAL ENVIRONMENTAL CONDITIONS..............................................................................................60

S.15.1.2 - SLIPS, TRIPS AND FALLS .....................................................................................................................61

S.15.1.2.1 - Manlifts ....................................................................................................................................62

S.15.1.2.2 - Aerial Work Platforms...............................................................................................................62

S.15.1.2.3 - Non-Permanent Scaffolding......................................................................................................62

S.15.1.2.4 - Ladders.....................................................................................................................................62

S.15.1.2.5 - Overhead Hazards....................................................................................................................63

S.15.1.2.6 - Machinery Hazards...................................................................................................................64

S.15.1.3 - ENERGY HAZARDS ............................................................................................................................64

S.15.1.3.1- Thermal Energy..........................................................................................................................64

S.15.1.3.2 - Residual Energy ........................................................................................................................64

S.15.1.3.3 - Electrical Energy .......................................................................................................................64

S.15.1.3.3.1 - Electrical Systems..................................................................................................................65

S.15.1.4 - POWERED INDUSTRIAL VEHICLES.........................................................................................................65

S.15.1.4.1 - Forklifts.....................................................................................................................................65

S.15.1.4.2 - Moving Cranes..........................................................................................................................65

S.15.1.4.3 - Mobile Elevated Work Platform (MEWP)..................................................................................65

S.15.1.4.4 - Semi Trucks...............................................................................................................................65

S.15.2 - RADIATION HAZARDS..................................................................................................................66

S.15.2.1 - EXAMINATIONS WITH NON-IONIZING RADIATION HAZARDS .....................................................................66

S.15.2.2 - EXAMINATIONS WITH IONIZING RADIATION HAZARDS .............................................................................66

S.15.2.2.1 - When to stop examinations/collections due to Ionizing Radiation Hazards .............................67

S.15.2.3 - RADIOACTIVE PRODUCT SAMPLING......................................................................................................67

S.15.2.3.1 - Sampling Instrumentation with Radiation Hazards..................................................................67

S.15.3 - ANIMAL HAZARDS .....................................................................................................................68

S.15.3.1 - DOG BITES/ATTACKS .........................................................................................................................68

S.15.4 - SPECIFIC INDUSTRIES ..................................................................................................................69

S.15.4.1 - GRAIN HANDLING FACILITIES ..............................................................................................................69

S.15.4.2 - RAIL SAFETY ....................................................................................................................................70

S.15.4.2.1 - Railyards...................................................................................................................................70

S.15.4.2.2 - Railcars.....................................................................................................................................70

S.15.4.3 OTHER INDUSTRIES.............................................................................................................................70

S.16 - ERGONOMIC ................................................................................................................................ 70

S.16.1 - FORCE....................................................................................................................................71

S.16.2 – AWKWARD, SAME POSTURE/IMPROPER ADJUSTMENTS.......................................................................71

S.16.3 - REPETITION .............................................................................................................................71

S.16.4 - COLD TEMPERATURES ................................................................................................................71

S.16.5. - VIBRATION .............................................................................................................................72

S.16.5 - SPECIAL ERGONOMIC SITUATIONS..................................................................................................72

S.16.5.1 - SAMPLING.......................................................................................................................................72

S.16.5.2 - PROCESSING EQUIPMENT INSPECTION..................................................................................................72

S.17 - EMPLOYEE AND TRAVELER HEALTH AND SAFETY .......................................................................... 72

S.17.1 - FDA OCCUPATIONAL HEALTH SERVICES (OHS) .................................................................................72
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S.17.2 - IMMUNIZATIONS .......................................................................................................................72

S.17.2.1 - DOMESTIC WORK.............................................................................................................................73

S.17.2.2 - FOREIGN TRAVEL..............................................................................................................................73

S.17.3 - PHYSICAL EXAMINATIONS ............................................................................................................73

S.17.4 - TRAVELER HEALTH.....................................................................................................................73

S.17.4.1 - DOMESTIC TRAVEL ...........................................................................................................................73

S.17.4.2 - FOREIGN TRAVEL..............................................................................................................................73

S.17.4.2.1 - Pre-Travel .................................................................................................................................74

S.17.4.2.2 - During Travel ............................................................................................................................74

S.17.4.2.2.1 - Medical Emergencies and/or Medical Assistance Abroad.....................................................74

S.17.4.3 - TRAVEL HEALTH KIT ..........................................................................................................................75

S.17.4.4 - GENERAL PRECAUTIONS DURING TRIP..................................................................................................75

S.17.4.5 - ADDITIONAL TRAVEL RESOURCES .........................................................................................................76

S.17.4.5.1 - Travel.State.Gov.......................................................................................................................76

S.17.4.5.2 - CDC Travelers’ Health ...............................................................................................................76

S.17.5 - EMPLOYEE AND TRAVELER SAFETY..................................................................................................76

S.17.5.1 - EMPLOYEE SAFETY............................................................................................................................76

S.17.5.2 - TRAVELER SAFETY TIPS ......................................................................................................................76

S.17.5.3 - MOTOR VEHICLE SAFETY ...................................................................................................................77

S.17.5.3.1 - Global Road Safety ...................................................................................................................78

EXHIBITS ................................................................................................................................................ 79

EXHIBIT S-1 - ORA “QUICK STEPS” EMPLOYEE’S GUIDE TO INCIDENT REPORTING .................................... 79

EXHIBIT S-2 - ORA “QUICK STEPS” SUPERVISOR’S GUIDE TO INCIDENT REPORTING ................................. 81

INDEX .................................................................................................................................................... 83
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Note: Certain links in this chapter are only available to FDA employees via the FDA Intranet site and 

cannot be accessed by individuals outside the FDA internal network. Requests for information can be 

made through the Freedom of Information Act (FOIA) process described in IOM Section 8.1.3.

S.1 - Purpose 

The purpose of this chapter is to give you the basic knowledge and skills to anticipate, recognize, 

evaluate, and apply control strategies to eliminate or minimize hazardous conditions and unsafe 

practices encountered during field investigations and inspections.

A hazard is defined as any source of, or the potential for, injury, damage, harm, adverse health effects,

or death. Hazards include any substance, material, activity, or process that has the potential to cause 

harm or injury. 

Workplace hazards are classified into various categories. Hazard categories addressed in this chapter 

include traumatic injury, biological/chemical/ergonomic/physical agents, and radiation.

Due to the unlimited variability of potential safety situations, it is not feasible to describe in the 

Investigations Operations Manual (IOM) what to do in each and every instance. The decision of what to 

do in each individual circumstance rests with you and your program/division management.

Personal Safety will not be discussed in detail in this chapter. The Personal Safety section below will

currently continue to reference IOM Chap 5.2.1.2 until further notice.

S.2 - Unacceptable Risk 

Most environments in which ORA conducts investigations or inspections contain identifiable risks. This 

chapter discusses many hazards found in regulated industries and describes approaches to protect ORA 

employees by reducing risks to acceptable levels. However, special consideration must be given when 

unacceptable risks are present. This section is intended as a framework to help investigators and their 

supervisors decide whether it is too unsafe to continue an investigation. It is critical to focus on 

plausible risks to investigators’ wellbeing, and not to base these decisions entirely on regulations or 

definitions.

First and foremost: If you suspect that conditions in your work environment may harm you, take 

immediate and reasonable steps to avoid those conditions. If the decision may impact completion of 

your assignment, let your supervisor know right away.

While it is not possible to cover every possible situation in a single guidance document, some situations 

that should always be considered as unacceptable risks include:

• If you doubt your ability to perform an activity safely, e.g., walking on a layer of ice.

• If you feel there is a reasonable chance of a non-trivial injury or illness, e.g., close proximity to 

unguarded machinery, or exposure to an infectious disease.

• If you suspect that you might be exposed to a hazardous chemical above an established 

occupational exposure limit such as an OSHA Permissible Exposure Limit (PEL).

“Reasonable” steps will depend on the situation. While it would certainly be reasonable to avoid using 

an unstable flight of stairs, it probably would not be reasonable to end the investigation and leave the 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER S 

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premises because of them. Encountering pervasive hazards throughout a firm, or a single hazard with 

life-threatening implications (e.g., plausible risk of a serious chemical release or an explosion), would 

likely make leaving the premises a reasonable step. If in doubt, move to a safe location and contact your 

supervisor for guidance.

Take a similar approach to situations or conditions that make it difficult to complete your assignment

but might not present a plausible risk of injury. Some investigations may occur in environments that are 

hard to tolerate due to physical discomfort, irritating materials or similar conditions. If you follow the 

advice in this chapter for dealing with factors like temperature extremes or eye irritants, and still have 

difficulty tolerating the environment, move to a better location and contact your supervisor.

ORA’s Office of Safety is available for consultation. Investigators and their supervisors can reach out to 

their supporting Industrial Hygienists or the Office of Safety leadership team. 

S.2.1 - C.O.V.E.R. (Control, Observe, Vary, Exit, Report) 

A tool that you can use to maintain safety awareness generally, and in instances where a safety or 

health hazard puts you at unreasonable risk of death or serious injury or illness, is to remember the 

mnemonic C.O.V.E.R.: Control, Observe, Vary, Exit, and Report.

S.2.1.1 - Control 

First, psychologically and physically CONTROL your environment as much as possible. 

• Maintain awareness of your surroundings as you perform inspectional activities. Always 

remain cognizant or conscious, of what is going on around you.

• Exhibit and maintain a professional attitude, driven by the reason that you are there, with a 

specific mission or task to accomplish.

• Carry yourself in a confident and professional manner--one that commands respect and 

cooperation.

S.2.1.2 - Observe 

Carefully OBSERVE the environment and those within it during inspectional activities. 

• Assess the exterior and interior environmental factors to identify potential hazards and/or 

dangers, and to locate escape routes and exit points.

• Consider behaviors of firm employees, such as threats, aggressiveness, awkward behaviors, 

and movements, etc.

• Look closely for weapons, anything that someone could potentially use as a weapon, or 

other physical hazards that may present safety concerns.

S.2.1.3 - Vary 

VARY your tactics, techniques, or approaches based on what you know, observe, and experience.

Review the firm’s establishment inspection file and pay special attention to anything that causes you 

to be concerned about your safety (including such examples as a questionable geographic location, 

or noted questionable/suspicious firm behaviors, animals, etc.). Note existing personal safety flags 

in the firm file. Adjust your approach as warranted.

S.2.1.4 - Exit 

Have an EXIT strategy in mind before you enter the establishment. Locate escape routes and exit 

points ideally before, or as you enter, the establishment.
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S.2.1.5 - Report 

REPORT the status and progress of your interviews, inspections, and other contacts.

• Tell your supervisor about any problems, threats, and safety concerns immediately.

• Generate a Personal Safety Alert (PSA) when warranted.

S.3 - Personal Safety 

Personal safety entails protecting the physical and mental safety, health, and welfare of FDA employees.

It also involves active engagement on your part and a general recognition and avoidance of possible 

harmful situations, or persons, in your surroundings. Basically, personal safety allows you to conduct or 

support field activities in a safe and effective manner. ORA managers should ensure that their 

employees have the resources and training they need to conduct their work safely, and that their 

employees keep abreast of and follow safety procedures.

First and foremost, if during inspectional activities, you determine there is the possibility of a threat to 

your personal safety or if you are assaulted (either physically, or put in fear by threats of physical/verbal 

violence), you should:

• Immediately disengage.

• Exit the premises.

• Get to safety.

• Contact the police as necessary.

• Get medical attention if needed.

• Call your supervisor.

ORA considers the safety of all staff who meet with regulated industry to be of utmost importance. 

Personal safety concerns can be further defined as those risk factors and circumstances that you should

be aware of which constitute a possible threat or compromise to your safety while conducting an 

inspection. These include, but are not limited to: 

• Situations in which another party initiates an assault (including both physical and verbal 

assaults) upon you or your colleagues; displays force (including the show or use of weapons,

aggressive animals, or other similar tactics); or otherwise communicates resistance towards you 

or the work you are engaged in.

• Firms with a known or suspected history of potential violence, either agency-documented (via 

an inspection report, memo, PSA/flag, or other resource) or suspected (via reports from media, 

other federal agencies, law enforcement, neighbors, etc.).

• Situations of heightened security or vulnerability due to political, social, and economic factors or 

unrest, etc.

• Work assignments that involve Office of Criminal Investigations (OCI) and/or other federal 

agencies, as they tend to constitute more complex, potentially multi-jurisdictional activities.

• Firms associated with suspected illegal/criminal activities, tampering incidents, or any other 

suspicious activities, occurring both on-- and off-site.

• Work assignments that warrant visits to any private or remotely located residences.

• PSA-flagged firms or firms associated with prior personal safety plans.
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• Work sites located in questionable or potentially unsafe surroundings (remote areas and/or high 

crime areas, etc.).

• Situations in which specific personal protective safety equipment is warranted.

• Situations in which a particular inspection may be medically contraindicated for some FDA

personnel.

When these and similar conditions are noted prior to inspectional activities, you should discuss the 

situation with your supervisor. When these conditions are encountered without prior knowledge during 

inspectional activities, follow IOM sections S.2 and S.3 of this chapter to immediately mitigate any 

hazards and then notify your management as soon as you are able.

If the inspectional activity is deemed a personal safety risk, your supervisor can assist in assembling a 

team to create a Personal Safety Plan (PSP) prior to performing the assigned work. The PSP should be 

cleared and approved prior to the start of any inspectional activities. See IOM Chapter 5 for Personal 

Safety Plan information.

If a PSP is established, your supervisor will contact the local police/law enforcement to notify them of 

the situation and the potential hazards, as well as to brief them on the approval or resolution of the 

PSP. Your supervisor can also request assistance from the Federal Protective Service (1-877-437-7411) 

or contact OCI headquarters for additional assistance (301-294-4030). While OCI does not normally 

provide physical security in such cases, they will assist in threat evaluation based on specific facts 

provided and available criminal databases. OCI can also make contacts, on your behalf, with local police 

and federal agencies, based on their previous established liaisons (United States Marshals, Federal 

Bureau of Investigation (FBI), etc.).

Tips to maximize your personal safety:

• Prepare for your inspectional activities with safety in mind and attempt to anticipate any issues.

• Formulate an exit/backup plan.

• Don’t make yourself vulnerable by being distracted, disorganized, or inattentive/negligent.

• Move with confidence, focus, intention, purpose, and assertiveness.

• Pay attention to your surroundings and the people around you.

• Trust yourself and your instincts and avoid anything, anyone, or any situation that does not feel 

safe.

• Immediately report suspicious activity to your supervisor.

S.3.1 - Uniform Use 

Uniform use, particularly by FDA Imports and PHS, has been a long-standing issue regarding personal 

safety. There are times when uniforms can potentially contribute to the perception of FDA as a threat 

and may create more volatile situations, especially during activities with certain commodities (tobacco, 

produce, raw milk....) or types of inspections (license revocations, outbreaks, injunctions...). 

Uniformed, and therefore identified, regulatory personnel could possibly become targets while 

performing their duties. If you determine that there might be a personal safety hazard to wear your 

uniform in certain locations, situations or during specific activities, consult with your management 

immediately. Be sure to provide facts and details to support your concern(s).
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Refer to IOM 5.2.1.2 - Personal Safety for additional personal safety concerns and information. 

S.3.2 - Personal Safety Alerts (PSA) 

During your review of eNSpect/Field Management Services (FMS), you should determine if any personal 

safety concerns exist. Prior to the start of your inspection, previously noted concerns will be flagged in 

the Firm field within eNSpect/FMS. Online Search and Retrieval System (OSAR) also prompts you to 

check the firm’s files for a PSA Memo, which, if in existence, provides an explanation of why a firm was 

flagged. PSA Memos are filed on the left-hand side of the establishment file jacket and printed in eyecatching color so to be easily recognized. If the PSA indicates a firm has any documented associations 

with, or history of, personal safety threats, you should discuss these details with your supervisor and 

evaluate whether a PSP is warranted, prior to the start of the inspection. 

Refer to this chapter, Field Alert 16 and IOM Chapter 5 if you encounter any personal safety issues—

including, a threat to your personal safety, a need for specific Personal Protective Equipment (PPE), or

circumstances posing medical contraindication risks (for example, staff with penicillin allergy potentially 

exposed to penicillin). First and foremost, take immediate steps to mitigate any hazards or threats. Once 

you are safe, including being potentially moved to another location, and after discussion with 

management, you should check the PSA flag field box associated with the firm in eNSpect/FMS so as to 

alert other investigators of the experienced threats to safety.

In eNSpect, the person creating an assignment can add PSA information on the Firm page by checking 

the flag box and utilizing the additional text box. This field is editable any time after the assignment has 

been created. This PSA tab will be selected when a firm, or inspection site, is affiliated with a potential 

hazard, including any of the following: 

• A history of physical, verbal, or other types of threats or assaults; or other forms of physical 

resistance.

• A need for specific PPE, including respirators. 

• The presence of medical risks, including those affecting specific investigator populations, such as 

women of child-bearing years who may be exposed to drugs known to be potentially hazardous 

to them; or individuals with allergies to peanuts, penicillin, or other products who may 

incidentally encounter those products or ingredients on site as part of their work.

When a personal safety concern is encountered, a PSA should be documented in the Endorsement text

and in a Memo to the File. The Memo should be titled “Memo To File - Personal Safety Alert” and 

includes factual information to support the alert. Such details will also serve as critical background 

information for colleagues and future investigators who will also be consulting eNSpect for safety issues. 

As with other evidence, ensure the memo is factual when documenting PSA details, as it could later be 

used for legal purposes/proceedings and may result in a court case. 

In addition, the Memo should: 

• Be filed in the official establishment file jacket, with copies sent to all resident posts and import 

program divisions who may interact with the relevant firm. 

• Be filed on the opposite side of the folder from all other documents and printed on eye-catching 

colored paper to be noticeably visible to the next investigator. 

• Be retained and maintained at the program division office. 
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• Be sent to orahqcsosafety@fda.hhs.gov. 

The supervisor and/or other program division management will be responsible for evaluating the need 

for any corrective actions to be taken by the firm, or individual, to remove or stop the potentially

dangerous situation, circumstance, or condition. Follow-up inspections at the facility should continue to 

document the status of the ongoing safety situation, including its cessation. If the safety situation ceases 

or is resolved (by new management, dismissal of an employee, or removal of penicillin in a facility, etc.),

the PSA should then be end dated as per IOM S.3.1.1.3 from eNSpect/FMS with required explanation. 

To view PSA details in eNSpect: 

1. Select “New Assignment”, then 

2. Select “Firm”. 

3. Enter the applicable FDA Establishment Identifier (FEI) and click “Look Up.” If a PSA exists and is 

active, it will be indicated to the right of the firm’s name. 

4. Select the “Details” button to display PSA details, and

5. select “View/Update” to display the reason, or basis, for the PSA. 

Additionally, an internal Online Reporting Analysis Decision Support System (ORADSS) report, FIR055 

Personal Safety Alert for a Firm by Home District (located in ORADSS under the Firms report folder),

provides comprehensive, sortable information on PSAs (any relevant threats, PPE specifications, etc.) 

associated with PSA-flagged firms, including information on alert type, reason for the alert, and other 

remarks. This report should be used prior to field activities to prepare for personal safety situations. The 

report is searchable by FEI, district, state, country, and/or program area. 

Refer to IOM Section 5.2.1.3 for more information about the PSA.

S.3.2.1 - Steps to creating a PSA 

Detailed instructions with examples on how to create and edit PSAs can be found in the current 

eNSpect user manual at eNSpect Help References. When first accessing a firm page, the active PSA 

will appear as ‘No’ by default when no FEI is present. Once the FEI is added, you will see an option to 

add or edit the PSA. After operation creation, PSAs are editable. 

S.3.3 - Personal Safety Training 

S.3.3.1 - MP118 Interviewing Skills and Personal Safety Reports 

Geared towards new FDA investigators and analysts, this instructor-led course provides participants 

the ability to successfully plan an on-site regulatory inspection while maintaining personal safety.

S.3.3.2 - MP8001S: ORA Personal Safety and Inspections Refresher 8 Part 

Training Series 

This course chronicles the history of how ORA became involved in providing meaningful, interactive 

training to keep our Investigators and Analysts safer during inspections. This multi video series 

course describes the difficulties faced by Investigators and analysts during inspections and identifies 

tools that can be used to gain additional knowledge about firms prior to inspection that could help 

keep staff safer. How to create a Personal Safety plan is defined during this video series and 

necessary elements required in the plan are explained in detail. Also provided are basic evasive 
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tactics to use if necessary to escape from a physical altercation. Though open to all FDA, the target 

audience is ORA employees who conduct inspections, those who supervise inspectional employees, 

Compliance Officers, DCBs, DIBs and HQ staff involved in approval process of Personal Safety Plans 

or scheduling of ORA inspections. This training applies to all commodities and program areas.

S.4 - Employer/Employee Safety Responsibilities 

Safety in all ORA work environments is foundational to our public health mission. The OSH Act requires 

employers to comply with hazard-specific safety and health standards. In addition, pursuant to Section 

5(a)(1) of the OSH Act, employers shall provide their employees with a workplace free from recognized 

hazards likely to cause death or serious physical harm. 

Safety is the responsibility of FDA employees, supervisors, and management. The agency will not allow

employees or supervisors to disregard established or otherwise reasonable safety precautions and 

thereby place themselves, and/or their fellow employees, and/or the agency’s facilities, at risk.

The FDA strives to provide a safe, healthy, and injury-free work environment for employees and 

promote a positive safety culture in which all employees value safety and behave in ways that prioritize 

their own safety, as well as the safety of their colleagues, and others around them. 

You have a responsibility for your own safety and an obligation to observe established health and safety 

rules and precautions as a measure of protection for yourself and others. You will not engage in willful 

misconduct that causes or will likely cause the FDA to be in violation of any rule, regulation, order, 

permit, or license issued by a regulatory authority. 

You are required to become familiar with and observe health- and safety-related policies, procedures 

and guidelines. If provided with safety equipment, PPE, or any other devices and procedures necessary 

for your protection, you will use such equipment and procedures as directed. Respirator use should

include consultation with your supervisor, in conjunction with the ORA Safety Office. 

While performing assigned work, be alert to the presence of potentially unsafe or unhealthy conditions. 

When such conditions are observed, it is your right and responsibility to report them. Determine if these 

conditions warrant disclosure to OSHA. In the case of imminent danger situations, after first ensuring 

your own safety, alert your management immediately. In such situations, you should C.O.V.E.R. when 

you have a reasonable belief that, under the circumstances, the task or area poses an imminent danger.

S.4.1 - Safety Incident Reporting 

The Office of Laboratory Safety (OLS) and the ORS Safety Workplace Incident Reporting site require the 

reporting of all work-related incidents, injuries, near misses, and property damage through the portal 

for Occupational Safety and Health (pOSH+). (A near miss is defined as an event in which no property is

damaged, and no personal injury or exposure sustained, but where—given a slight shift in time or 

position—damage, injury, and/or exposure could have easily occurred. An example: A workplace shelf 

collapses and narrowly misses striking an employee.) The process of reporting any workplace incidents 

in the pOSH+ ensures incident investigation, mitigation, and corrective actions are completed with the 

intent to prevent future occurrences. 
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ORA employees can use the portal to directly submit workplace incident reports to their supervisor and 

the ORA safety team for further investigation. Incident reporting in pOSH+ can be done through use of a 

desktop icon or from any FDA mobile device. Incidents of property damage, without employee injury, 

may only require reporting through pOSH+. Your supervisor will automatically be notified via pOSH+ 

email. Your supervisor will then visit pOSH+ to review your submission before the incident is 

investigated by your Center/Office Occupational Safety and Health Officer (OSHO). If you visit an FDA 

Occupational Health Clinic as a result of an incident, the clinician will submit the report on your behalf to 

your Center/Office OSHO and you will not need to enter a report via pOSH+.

Additional incident reporting may also be required through the Employees' Compensation Operations 

and Management Portal (ECOMP). The support Industrial Hygienist (IH) for your program or division is 

available to provide support and additional information for incident reporting. Users can report these 

four types of safety-related incidents/events: 

• Injury, Illness, or Potential Exposure, which is defined as an occupational event resulting in bodily 

injury (for example, due to a slip, trip, or fall), illness, or a potential exposure (for example, of 

chemical, biological, or radiological origin) to an individual.

• Property Damage, which is defined as an unplanned, undesired event that resulted in FDA 

property damage without perceived injury or exposure.

• Near Miss, which is defined as an event wherein no property was damaged, and no personal 

injury sustained, but where—given a slight shift in time or position—damage and/or injury could 

have easily occurred, as defined by OSHA.

• Event of Concern, which is defined as a safety concern or non-compliance event.

OLS has developed a SharePoint page for implementation of pOSH+ that includes frequently asked 

questions, resources, and training videos to assist employees, supervisors, and safety personnel in 

reporting and investigating workplace incidents. Information submitted through this portal will assist the 

FDA in the development of recommendations and corrective actions to improve safety. 

Reference the following resources for incident reporting: 

• ORA “Quick Steps” Employee’s Guide to Incident Reporting (Exhibit S-1) 

• ORA “Quick Steps” Supervisor’s Guide to Incident Reporting (Exhibit S-2) 

In addition, be alert to any problems associated with defective or misused equipment, or supplies, and 

their possible impacts on yourself and others. Contact your supervisor and/or the headquarters contacts 

listed in the applicable compliance program as necessary for assessment. The home division of the 

manufacturer should be notified of firm product misuse, so it may be brought to the manufacturer’s 

attention for consideration of precautionary labeling or redesign of the product. Your pOSH+ report 

should fully document these problems, to include the hazard and/or defect observed, and whether or 

not user actions could be a contributing factor. Documentation should present sufficient data, such as 

photos and diagrams, to supplement a narrative describing the situation, as well as the collection of 

samples if applicable.

S.5 - Following Firm Safety Requirements 

You should always follow any applicable and appropriate safety requirements set by firm, unless

otherwise instructed by your supervisor or management (for instance, employee concerns or pre-
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existing safety issues). A firm’s safety requirements should also not hinder your ability to perform your 

duties. If you should experience doubt, confusion, or concerns regarding any safety requirement, seek 

clarification from the firm if possible. If you still have concerns, contact the FDA ORA Safety Program. 

When conducting activities in facilities requiring the use of PPE, the following guidance should be 

provided by the firm’s management:

• Information about the specific hazards present - including symptoms of exposure that may be 

encountered. 

• Information regarding the potential levels and/or concentrations of stated hazards present. 

The firm’s management should be able to provide you with documentation showing how hazards were 

determined, what the expected exposures are, and how they relate to the OSHA Permissible Exposure 

Limit (PEL). Such documentation should also offer information about the PPE that will protect you 

against a hazardous exposure. If you have any doubts about the hazards or doubts about the 

effectiveness of the equipment recommended or provided to protect against them, do not enter these 

areas. The Safety Liaison for your program or division, or the ORA Safety Office, will be able to help you 

evaluate the information provided to you and will furnish information regarding the hazard, as well as

the recommended PPE.

If you do not have the specific PPE recommended by the firm’s management, request the needed 

equipment from your division. In some cases, the firm may be willing to provide the necessary PPE;

however, if respiratory protection is required, you should comply with ORA's Respiratory Protection 

Program. You should only use respirators provided by FDA, unless your Division’s IH, or the National 

Safety Office, has approved the use of other devices. It is ultimately your responsibility to ensure that 

you do not expose yourself to any hazard.

S.6 – Safety Risk Assessment Frameworks 

ORA’s Safety Office uses a risk-based approach to assessing, classifying, and mitigating occupational 

hazards, relying on risk assessments to help determine if procedures and/or protective measures are 

adequate. 

Using, ORA Safety staff can apply a basic procedure for risk-based criteria and make a risk assessment. 

Contact the ORA Safety program for any hazard questions, concerns, or classifications guidance. Note 

that when consulting with ORA’s Safety Office for assistance with occupational hazards encountered, 

you may be asked to supply information that will be used to perform a risk assessment so that you can 

receive the most appropriate guidance on how to proceed.

S.7 - Additional Safety Information 

S.7.1 - FDA/ORA Safety Programs 

S.7.1.1 - FDA ORA Safety Program 

The ORA Safety Office develops safety policy, training, and information for all ORA employees. 

ORA industrial hygienists work with ORA programs at all levels to develop the best possible safety 

guidance. Site topics include dangerous goods, hazard assessments, hazard communication 
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resources, hazardous waste management, radiation/laser safety, respiratory protection resources, 

safety training, safety labels, and workplace incident reporting.

S.7.1.1.1 - Industrial Hygiene (IH) Contact List

The ORA Safety Office, part of the Office of Regulatory Science (ORS), has a staff of IHs stationed 

at most of ORA’s laboratories. The IHs serve as points of contact and subject matter experts for 

safety issues throughout ORA. Each IH covers one or more districts and provides safety support 

to all ORA staff located within their assigned districts’ geographic boundaries. Many IHs also 

provide focused support to one or more ORA programs.

S.7.1.1.2 - ORA Safety Office FAQs

Frequently asked questions addressed by the ORA Safety Office cover topics including, general 

safety, employee protection, radiation safety, opioid sampling and analysis, laboratory 

environmental management, shipping of dangerous goods, and shipping of hand sanitizer.

S.7.1.1.3 - ORS Safety Hazard Assessments Grab & Go's

Grab and Go documents are Hazard Assessment documents, organized by program, that provide 

essential safety information for ORA field investigators and lab analysts. They provide one-page 

overviews of safety requirements for specific tasks. Investigators and analysts should review the 

documents relevant to their tasks to ensure awareness of safety requirements. 

Each document includes: 

• An overview of hazards.

• Required personal protective equipment.

• Respirator guidance.

• Training requirements. 

• Other relevant topics, e.g., radiation safety or medical surveillance requirements.

S.7.1.1.4 - Office of Security and Emergency Management (OSEM)

OSEM protects FDA's personnel, facilities, and information from threats and ensures that FDA is 

prepared to manage emergencies and incidents, including those involving FDA-regulated 

products.

S.7.1.2 - Occupational Safety and Health (OSH) Program 

The OSH Program strives to improve occupational safety and health through training, 

communication, and the implementation of initiatives that will achieve measurable results. This site 

offers the following resources, including, but not limited to: 

• Hazard exposure self-assessment tools.

• Safety training.

• Safety and health information.

• Safety manuals.

• Preparedness resources.

S.7.2 - Emergency Response/Incident Command 

You may be assigned to perform activities in which an Incident Command Structure (ICS) has been 

implemented. These situations may involve hazards posing a threat to human health and/or the 

environment. Examples of incidents that would be expected to have an active ICS structure include 

disease/illness outbreaks, special or national security events, chemical spills/hazardous waste sites, and 

natural disaster situations. 
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The Incident Management Team (IMT) will be responsible for tactical operations, to include performing 

investigations/inspections, collecting samples, and/or detaining or destroying contaminated product, 

and executing any other safety related functions in accordance with the Incident Action Plan (IAP) and 

safety plans, if appropriate. 

If you are involved in a situation operating under an ICS, IMT or Incident Management Group (IMG), 

your reporting structure exists through that command staff; you shall follow the ICS management 

guidance or guidance provided by the ICS/IMT/IMG. 

There is always the potential that unprotected personnel will not be permitted into hazardous zones for 

safety reasons. If the event has sufficient safety concerns to warrant a safety officer, safety 

consultations will be made in conjunction with that individual, through the ICS/IMT/IMG structure. If no

safety officer is assigned, safety consultations will be conducted with your IH contacts, in conjunction 

with the ICS/IMT/IMG structure.

Also reference IOM 8.1.5.8 for information on FDA investigations in the aftermath of disasters. 

S.7.2.1 - Office of Emergency Management (OEM) 

The Office of Emergency Management (OEM) serves as the FDA focal point for coordinating 

emergency response activities involving FDA-regulated products. The office coordinates intra-agency 

and inter-agency activities related to crisis management and emergency preparedness and 

response, including the planning, conduct, and evaluation of emergency scenario 

tabletop/simulation exercises. OEM develops, manages, and coordinates incident management 

plans, policies, and programs for the FDA to ensure that an agency structure exists to respond 

rapidly and effectively to all hazards. OEM provides strategic direction and oversight of the FDA’s 

adoption of the National Incident Management System (NIMS), including all aspects of the 

development of plans, procedures, and training programs in support of the ICS.

S.7.2.2 - Office of Emergency Operations (OEO) 

The Office of Emergency Operations (OEO) serves as the FDA's central emergency coordination 

point with FDA headquarters, centers, and field offices. The OEO leads the following activities:

• Provides interagency coordination and response to adverse events, foodborne illnesses, 

injuries, product tampering, and man-made and natural disasters.

• Assists in the development of emergency operations plans and incident-specific annexes, 

and the design, implementation, and presentation of associated training and exercise 

programs.

• Represents the agency at federal, state, local, and foreign government meetings and 

workgroups on emergency preparedness and response.

• Provides a nationwide, 24-hour, seven-days-a-week emergency response system.

• Manages the National Consumer Complaint System.

S.7.2.3 - Additional Emergency-related Sites 

• Coordinated Outbreak Response and Evaluation (CORE)

Through CORE, the FDA combines expertise in medicine, public health, and science to 

coordinate its efforts to find, stop, and prevent foodborne illness outbreaks.

• ORA Emergency Response Coordinator (ERC) Site
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ERCs are dedicated to emergency response activities, exercises, training, and 

collaborations with federal, state, and local partners. ERCs are active in emergency response 

activities, engaged in all facets of emergency preparedness and response, and provide 

enhanced response capabilities for FDA/ORA. ERCs train and support the implementation of 

the ICS filling vital Command positions at HQ and in the field. ERCs provide support to State 

Rapid Response Teams (RRTs), as well as CORE.

• Continuity of Operations Plan (COOP)

Continuity of Operations (COOP) is the initiative that ensures federal government 

departments and agencies can continue operations of their essential functions under a 

broad range of circumstances, including all-hazard emergencies, as well as natural, manmade, and technological threats, and national security emergencies.

• FEMA Preparedness (Ready.gov)

Ready is a national public service campaign designed to educate and empower the American 

people to prepare for, respond to, and mitigate emergencies, including natural and manmade disasters. The goal of the campaign is to promote preparedness through public 

involvement.

• OSPOP's Emergency Preparedness Collaboration Site

The purpose of the OSPOP Emergency Preparedness Collaboration site is to provide a 

platform where the FDA can share information about emergency preparedness 

and associated topics. 

S.7.3 - Occupational Safety and Health Administration (OSHA) 

With the Occupational Safety and Health Act of 1970, Congress created the Occupational Safety and 

Health Administration (OSHA) to ensure safe and healthful working conditions for workers by setting 

and enforcing standards, and by providing training, outreach, education, and assistance.

S.7.3.1 - OSHA Memorandum of Understanding (MOU) 

FDA maintains a domestic MOU with OSHA to facilitate information sharing with respect to matters 

affecting the occupational safety and health of workers, and the safety and security of our nation's 

food supply in facilities where food is produced, processed, or held. The pertinent substance of 

MOU 225-11-0007 is that the FDA and OSHA will share relevant information with each other. If FDA

and/or OSHA, in their investigations of facilities where food is produced, processed, or held, has 

reason to believe that a potential violation of an FDA/OSHA standard is present, the agency noting

the potential violation(s) will provide this information to the other agency. This may include 

observations made directly by agency personnel, information provided to OSHA by a state 

participating in the OSHA State Plan program, as well as information received from other parties, 

including workers. 

S.7.3.2 - OSHA Severe Violator Enforcement Program (SVEP) 

Additionally, while the vast majority of employers want to protect their employees, there are others 

who continue to expose workers to very serious dangers even after receiving citations for hazards 

causing serious injuries, illnesses, and deaths. On June 18, 2010, OSHA instituted the SVEP to more 

effectively focus enforcement efforts on recalcitrant employers who demonstrate indifference to 

the health and safety of their employees through willful, repeated, or failure-to-abate violations of 

the OSH Act. You have the option, prior to going on an inspection, to review the OSHA-maintained 
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and publicly available SVEP Log detailing the names, locations, and citations of employers in the 

program. The link to the document can also be found on the OSHA Enforcement page in the Policy 

and Guidance section. OSHA updates the log at the beginning of every quarter.

S.7.4 - Other Safety Agencies 

After first checking with ORA’s Safety program, you can consult the following federal agencies for

additional sources of workplace safety information:

• U.S. Environmental Protection Agency (EPA)

• Occupational Safety and Health Administration (OSHA)

o All OSHA Publications 

o OSHA Fact Sheets

• The National Institute for Occupational Safety and Health (NIOSH)

NIOSH is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of 

Health and Human Services. NIOSH is a research agency focused on the study of worker safety 

and health and developing new knowledge in the field of occupational safety and health.

o NIOSH Fact Sheets and Publications

o NIOSH Emergency Response Safety and Health Database

o NIOSH Workplace Safety and Health Topics

o NIOSH Pocket Guide to Chemical Hazards

o NIOSH Pocket Guide to Chemical Hazards Mobile Application

S.8 - Hierarchy of Controls 

Although most investigations are conducted at sites FDA does not control, you are still able to take 

positive steps to mitigate hazards to which you might be exposed. The following information is provided 

to help you recognize effective mitigation options, and to approach occupational hazards using the same 

frameworks as the ORA Office of Safety’s Industrial Hygienists (IHs). 

The Hierarchy of Controls model ranks hazard control strategies from most to least effective in 

preventing injuries and illnesses. Although you typically will not be able to implement higher level 

controls such as eliminating hazardous machinery or reformulating products to remove hazardous 

chemicals, the overall philosophy can be helpful for comparing your feasible options. For example, 

requesting that the firm restrain an aggressive farm dog behind a barrier (an engineering control) will be 

more effective than trying to remain aware of the dog’s activities, and observing a hazardous chemical 

process from a safe location (another engineering control) will be more effective than wearing PPE while 

standing close to the process.
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The idea behind this hierarchy is that the control methods at the top of graphic are consistently more 

effective and protective than those at the bottom. Control methods are as follows: 

• Elimination and Substitution are usually limited to the design phase of a facility or process. 

Although you won’t be able to apply these to a firm’s facility, they are relevant to hazards of 

supplies and equipment you use during investigations. For example, a box cutter may be 

substituted for a pocketknife when opening packaged materials.

• Engineering controls either create a physical barrier between you and the hazard, or they 

physically remove a hazard before it can affect you. Classic examples are guards over pinch 

points on machinery, or exhaust ventilation to remove hazardous gases and vapors before they 

mix with the room air. Although you won’t be able to implement these at an investigation site 

in most cases, it’s important to recognize any existing engineering controls that are in use and 

not to interfere with their operation. 

• Administrative controls are an approach to limiting chemical exposure by reducing the length of 

time you are exposed, rather than reducing the amount of the chemical you are exposed to. 

Administrative controls rely on mathematical calculations of the total exposure and should not 

be relied on without concurrence from the ORA Office of Safety.

• Work Practice controls (not shown in the graphic above) are changes you make to the way you 

work, such as maintaining awareness of nearby hazards or attempting to use safe lifting 

practices. These are the least effective means of mitigating hazards, as the hazardous 

conditions are still present, and you are depending on your own vigilance for protection.

• PPE is an essential part of the overall investigation safety practices, but it should be viewed as a 

last line of defense in case higher-level controls are not completely effective.
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S.8.1 – General Protective and Preventive Measures

Generally, the level of protection utilized during the inspection should be appropriate to the level of risk 

of exposure, and based on factors, such as, type of hazard present, potential exposure, the processes in 

which the hazards are being manipulated, and the potential outcome (injury) from exposure to the 

hazard. If exposure to hazards is a concern, or you feel at risk, exit to a safe area. Then contact your 

supervisor, or ORA Safety Office personnel, for additional guidance before proceeding any further. 

General protective and preventive measures and guidance includes:

1. Determine if the firm has established safety precautions and procedures and follow them if 

adequate.

2. If there are signs of tampering or counterfeiting with the product being examined or inspected, 

consult your IH contact and your supervisor for any additional safety precautions needed. Based 

on the situation, protection could consist of work gloves worn over surgical gloves, full face 

respirator with appropriate cartridges, disposable coveralls, and work boots. If the situation 

changes, evolves, or escalates, exit and report to your supervisor.

3. As much as possible, do not touch. This means equipment, materials, reagents, animals, etc.

4. Wear protective clothing. Evaluate the needs for gowns, caps, masks, gloves, and shoe 

coverings, etc. and wear them where necessary. Protective clothing worn in a work area where a 

virus or spore-bearing microorganism is handled should not be worn into a work area for 

another product. As much as possible and with firm consent, leave all used protective clothing at 

the firm for proper disposal. Otherwise, consult with your IH and be prepared to transport the 

used PPE yourself.

5. Wash hands thoroughly after leaving each work area.

6. If the firm is processing viruses or other potentially infectious biological agents during the 

inspection, determine if it is advisable to enter the work areas. Chances of infection through 

aerosols are reduced when there is no active processing.

7. Vaccines are available for your protection against some organisms (e.g., Rubella). For 

information on inoculations and physical examinations, refer to FDA Occupational Health 

Services (OHS).

S.9 - PPE 

PPE is protective clothing and equipment designed to reduce exposure to hazards and/or harm caused 

by hazards, prior to an exposure. You should identify and evaluate all hazards prior to selecting PPE. 

Ensure you have the proper training to use the needed PPE, and that the PPE is rated to protect you 

against the identified hazards.

Ideally, the primary means of protection from workplace hazards include avoiding hazards, remaining 

behind a barrier, or relying on engineering systems (such as exhaust ventilation) to physically separate 

from the hazard. However, due to the nature of ORA’s investigative activities and the industries we 

regulate, there may be situations in which physical separation from hazards is not possible. In those 

situations, PPE is used as a barrier between you and the hazard. Numerous types of PPE are available, 

depending on work conditions and the part of the body that might be susceptible to a hazard. It is 

advisable to remember that a hazard is still present when relying on PPE for protection; the PPE 

provides a margin of safety from it.
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Prior to any potentially hazardous situation, consult with your Industrial Hygienist (IH) Contact(s) if you 

are unsure as to the necessity for and/or adequacy of PPE. If you encounter situations in which you are 

not sure about the effectiveness of PPE, contact your supervisor and consult with your IH for guidance. 

If in any doubt about your safety, leave the area until all your concerns have been resolved. Also see 

Personal Protective Equipment - Overview OSHA and Personal Protective Equipment – OSHA.

Another aspect of safety/PPE is what clothing you wear during an inspection. Safety considerations, 

weather, type of work, hazards of the work, and many other factors will have an impact on what type of 

clothing is optimal for each situation you encounter. In addition to specific, situation-appropriate PPE, 

general clothing considerations/guidance are as follows:

• Be aware of drawstrings (for example, on hooded sweatshirts), ties, scarves, and other hanging, 

potentially entangling components of clothing and shoes (for example, shoelaces), as they can 

get caught up in rotating parts and on objects/equipment.

• Be aware of jewelry. Loose, protruding, or dangling jewelry poses safety risks when working 

around moving parts and machinery. As a note, OSHA prohibits conductive jewelry around live 

current since it can lead to an arc flash or blast, severe burns, the ignition of clothing, or 

electrocution. Metal jewelry also poses risks when in proximity to chemicals and has the 

potential to cause reactions. As jewelry can also harbor bacteria that cause food-borne illness, it 

is generally not recommended in food-handling facilities.

• Tie back long hair and use hairnets/hats to prevent entanglement. OSHA states that hair shall be 

“securely fastened” into a knot or bun without protruding pieces. 

• Do not carry notebooks, credentials, pens, etc., in the outer pockets of your inspectional 

uniform because they could fall into equipment.

• Glasses, keys, and ID badges dangling from cords or chains can be hazardous; instead, use 

breakaway safety cords or lanyards.

• Wear clothing that fully covers the body, including arms and legs. 

• Wear shoes that cover the entire foot, provide a stable platform, and have rubber or similar slipresistant soles. Also, wear socks that cover the ankle. 

S.9.1 - Eye and Face

Eye and face protection consists of safety glasses, face shields, and other specialized protective 

equipment. Safety glasses should be worn in environments where projective hazards exist, such as near 

grinding machinery. Face shields should be worn in environments where splash hazards to the eyes or 

face exist, such as near corrosive chemical dipping tanks. Specialized eye and face protection may be 

needed when working near processes involving electrical arcs and other sources of radiation. Consult 

with your supervisor and/or your IH Contact(s) if you encounter these situations. When selecting and 

purchasing general eye and face protection, ensure they meet American National Standards Institute 

ANSI/ISEA Z87.1-2020: Current Standard for Safety Glasses for impact resistance. For specialized eye and 

face protection needs and questions, consult with your IH Contact(s). 

S.9.2 - Head 

Head protection consists of hardhats and other specialized headwear. Hardhats should be worn in areas 

with overhead hazards, and specialized hardhats should be worn in areas where overhead hazards may 

present an electrical hazard. Specialized headwear may be needed when working in extreme 
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temperatures (hot or cold) or in situations where side impacts to the head are likely. Consult with your 

supervisor and/or IH Contact(s) if you encounter these situations. When selecting and purchasing 

hardhats, ensure they meet ANSI Z89.1 - Industrial Head Protection, Standard for Industrial Head 

Protection. ANSI Z89.1 - Industrial Head Protection, Standard for Industrial Head Protection. For 

specialized head protection needs and questions, consult with your IH Contact(s). 

S.9.3 - Foot 

Foot protection consists of crush-resistant boots/shoes, chemical-resistant boots/shoes, and other 

specialized foot coverings. Crush-resistant boots/shoes should be worn in environments where crushing 

hazards may impact the feet, such as in warehouses. Chemical-resistant boots/shoes should be worn in 

environments where hazardous chemicals may encounter the feet or lower legs. Specialized foot

coverings maybe needed when working in extreme temperatures, in deep mud or snow. Consult with 

your supervisor and/or your local IH Contact(s) if you encounter these situations. When selecting and 

purchasing crush-resistant boots/shoes, ensure they meet ASTM International standard 2413-18. When 

selecting and purchasing chemical-resistant boots/shoes, ensure that they are compatible for use in 

protecting against the specific chemicals of concern in the environment. For specialized foot protection 

needs and questions, consult with your local IH Contact(s). 

S.9.4 - General Body 

Body protection consists of protective clothing and suits. Protective clothing and suits should fit properly 

and provide protection against the hazard. An example of protective clothing is the use of cold weather 

clothing while working inside a freezer. Consult with your local IH liaison when selecting and purchasing 

protective clothing and suits needed to protect against hazards, which include but are not limited to, 

chemicals, fire, electricity, and other specific hazards. The protective clothing should fit you and be 

appropriate for the environmental conditions in which you are working. Note that protective clothing 

can be hazardous to the wearer if improperly fitted and/or not appropriate to the working or 

environmental conditions.

S.9.5 - Hands 

Hand protection consists mainly of gloves. Gloves should fit properly and provide protection against the 

hazard. An example is the use of chemically compatible gloves when handling chemicals. When selecting

and purchasing gloves, ensure they meet ANSI/ISEA 105-2016 standards for protection against cuts, 

punctures, abrasion, chemicals, heat, and/or vibration as applicable. Use appropriate gloves to avoid 

slivers and/or splinters when handling rough wooden cases or similar items. Use protective gloves when 

handling hot or cold items. Examples in which hand protection` would be warranted include working 

around steam pipes, or when handling frozen products or working in freezers. Use the appropriate, 

protective gloves when handling lead ingots containing radioactive materials to avoid hand 

contamination. If you are handling solvents, wear gloves that are impermeable to the solvent. Consult 

with your supervisor and/or your IH Contact(s) if you encounter situations in which you are unsure 

about which gloves to select for the task, or are unsure if the gloves made available to you provide 

adequate protection.
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S.9.6 - Hearing 

Hearing protection devices consist of ear plugs and/or earmuffs. Hearing protection should be used 

when ambient noise exceeds 85 decibels (dB), or when impulse noise (for example, a hammer strike) 

exceeds 140 dB. Noise levels are typically above 85 dB when face-to-face communication becomes 

difficult without shouting, and above 140 dB, when it is approximately as loud as a gunshot or explosive 

firework. 

 

When selecting and purchasing hearing protection devices, ensure they are EPA-rated and will reduce 

noise exposure to below 85 dB.

The NIOSH Sound Level Meter App is one tool available to the public to download on mobile iOS devices 

that measures sound levels and provides noise exposure parameters to help reduce occupational, noiseinduced hearing loss.

Consult with your IH Contact(s) if you are unsure if hearing protection provided to you is adequate. 

S.9.7 - Respiratory 

Refer to the ORA Respiratory Protection Program (RPP) (SOP-000449).

The purpose of the RPP is to establish uniform responsibilities and procedures in accordance with OSHA

Respiratory Protection Standard (29 CFR 1910.134) and FDA’s Respirator Protection Plan for the 

appropriate selection, use, and care of respiratory protection equipment issued to ORA employees.

ORA employees frequently perform work at worksites that are not under the control of FDA and may be 

exposed to physical, chemical, biological, and radiological inhalation hazards. When elimination, 

substitution or engineering controls are not feasible for protection against inhalation hazards, ORA

employees will use administrative controls to limit the duration of exposure. Respirators will be used in 

conjunction with administrative controls to minimize exposure.
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The ORA RPP addresses topics such as contacts, training, hazard assessment, respirator selection and 

respirator procurement. 

Note that, per OSHA, respiratory hazards can exist in various forms: They may be gases, vapors, dusts, 

mists, fumes, smoke, sprays, and fog. Some of these substances can cause illness and/or death if 

inhaled. Certain respiratory hazards act quickly, like carbon monoxide - an invisible, odorless gas - which 

can make you unconscious or kill you within minutes. Other respiratory hazards can take years to make 

you sick, like asbestos, which can cause lung cancer years, or even decades, after you’ve breathed it in. 

More examples of respiratory hazards include, but are not limited to:

• Dusts, such as those found when adding dry ingredients to a mixture.

• Metal fumes, from welding, cutting, and smelting of metals.

• Solvent vapors, from spray coatings, adhesives, paints, strippers, and cleaning solvents.

• Infectious agents, such as tuberculosis bacteria in healthcare settings.

• Chemical hazards, such as chlorine gas and anhydrous ammonia in chemical processing and use 

operations.

• Sensitizing vapors or dusts, such as isocyanates, certain epoxies, and beryllium.

• Oxygen deficiency, which might be found in confined spaces.

• Pharmaceuticals during the production of prescription drugs.

The following sources, sites, and situations have been identified as having the potential for respiratory 

hazards:

• Feed, drug, and tobacco plants. 

• Fumigation or storage facilities where treated grain or produce is encountered--including trucks, 

vessels, railroad cars, and fumigation chambers.

• Facilities using ozone (or where ozone is produced as a byproduct of the manufacturing 

operation), methyl bromide, phosphine, or sulfuryl fluoride.

• Facilities where sterilizers utilize ethylene oxide gas (EO).

• Grain elevators or other grain storage facilities, which may present asphyxiation hazards, toxic

decomposition gases, or pathological toxins such as aflatoxin.

• Spice grinders and repackers that potentially produce airborne respiratory irritants such as 

pepper.

• Any rodent-infested areas.

• Poultry houses, which generate exposure to particulates, chemicals, and possible infectious 

agents.

• Ammonia, which is still used in some facilities as a refrigerant and should be considered a 

potential hazard.

Respiratory Protection Resources can be found on the ORA Safety SharePoint site. OSHA’s Respiratory 

Protection - Overview also provides general guidance and resources. 

S.9.8 – Marine/Water/Flotation 

Employees working over or near water, where the danger of drowning exists, should consider U.S. Coast 

Guard-approved life jackets or buoyant work vests. Personal flotation devices (PFDs) mitigate harm 
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when there is a chance of falling into water such as working near unguarded edges, boarding or leaving 

small boats, or working from scaffolds or staging. Lifesaving equipment such as life ring buoys with ropes 

and ladders should be available when working from floats, barges, or vessels.

When working in and around water on an open boat where water temperatures are below 70°F, 

reference Cold Stress - Cold Water Immersion | NIOSH | CDC. Also consult your IH Liaison.

S.9.9 - Common PPE 

Common PPE to consider having on hand or to carry with you during inspections--not including specific 

inspection types warranting specialized PPE, such as egg, drug, Low Acid Canned Food (LACF), and 

others--include:

• Hard Hat

• Safety Shoes

• Hearing Protection

• Gloves

• Eye Protection

• Protective clothing, including coveralls, lab coats, reflective coats, freezer coats, rubber or vinyl 

aprons, and disposable paper-like coveralls

Always plan in advance for any PPE that may be required for a particular location or situation.

You may have an option to utilize PPE provided by a firm. Firms may request that you use PPE they provide 

in conjunction with their safety programs and practices. If possible, attempt to determine if the provided 

PPE is adequate, or at least comparable to your FDA-supplied PPE and is compliant with recognized 

standards. Evaluate the provided PPE for cleanliness and sanitary status (particularly eye and head 

protection). If you feel that the firm’s PPE is inadequate, do not enter and contact your supervisor or IH 

for next steps.

Additional non-PPE items that can be utilized in conjunction with your common PPE, include, but are not 

limited to, hair/beard nets, hand sanitizers, shoe covers, and face masks. Some of these items may be 

required by the inspected firm.

S.9.10 - PPE on/off sequence 

Below is a generalized sequence for putting on and taking off PPE. The type of PPE used will vary based 

on the level of precautions required, such as standard and contact, droplet, or airborne infection 

isolation precautions. Note that the procedure for putting on and removing PPE should be tailored to 

the specific type of PPE and situation encountered. Follow the firm’s procedures when required. If 

there are questions or concerns about a firm’s procedure, consult with your supervisor or IH Contact(s). 

Donning PPE (Putting on) as applicable Doffing PPE (Taking off)

1. Perform hand hygiene.

2. Put on shoes/shoe covers.

3. Put on lab coat.

4. Put on mask/respirator.

5. Put on eye protection.

6. Put on gloves.

1. Remove shoe covers/shoes.

2. Remove lab coat.

3. Remove gloves.

4. Perform hand hygiene.

5. Remove eye protection.

6. Remove mask/respirator.
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7. Perform hand hygiene.

The CDC Sequence for Donning and Removing Personal Protective Equipment pdf provides options for 

safely donning (putting on) and doffing (removing) PPE.

Doffing techniques are particularly critical to mitigate self-contamination. There are a variety of ways to 

safely remove PPE without contaminating your clothing, skin, or mucous membranes with potentially 

infectious materials. For example, in instances when using a respirator: Remove all PPE before exiting, 

except the respirator. Remove the respirator after leaving and closing the door. See CDC sequence 

document for this and other doffing options.

S.9.11 - Maintenance and Care of PPE 

• Note any expiration dates and/or manufacturer’s maintenance schedules (including 

recommended replacement periods and shelf lives) as applicable.

• Always inspect PPE for damage prior to donning (putting on) and after doffing (removing). 

• Clean and disinfect, if applicable, PPE before storing it.

• Dispose of and replace damaged PPE as necessary and whenever signs of integrity damage are 

apparent.

• Properly store PPE and avoid conditions that could potentially damage it, such as excessive heat, 

light, moisture, and humidity. 

• Do not store or use PPE in close proximity to chemical or biological hazards. 

• Plan to replace PPE on regular intervals even if no apparent signs of degradation are present. 

S.9.12 - Purchasing protective equipment 

ORA will provide required PPE for its employees. Employees can request safety shoes and/or 

prescription safety glasses by submitting completed request forms to their Supervisory Administrator 

Management Specialists (SAMs). ANSI-certified prescription glasses can be purchased from a vendor of 

your choice and convenience. ORA will pay pre-defined allotments for regular lenses/bifocal lenses for 

prescription safety glasses and for safety shoes. The cost of eye exams is not reimbursable. Employees 

are responsible for costs exceeding allowed allotments. Please refer to SOP-000123, Prescription Safety 

Eyewear and Safety Footwear, for further information and to access request forms A and B for safety 

glasses or shoes.

S.10 - ORA Safety Office 

The ORA Safety Office develops safety policy, training, and information for all ORA employees. 

ORA industrial hygienists work with ORA programs at all levels to develop the best possible safety 

guidance.

S.10.1 ORA Safety Contacts 

• Email ORASafetyOffice@fda.hhs.gov

• IH Contact List
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S.11 - Resources 

S.11.1 - Respiratory Protection Resources 

S.11.2 - QMiS 

QMiS is the repository for ORA’s internal procedural documents and quality reports, including 

documents on safety, standard operating procedures, work instructions, templates, checklists, 

transmittal notifications, and reports--all organized by component and document type. Safety related 

QMiS content includes, but is not limited to:

SOP-000449 ORA Respiratory Protection Program

SOP-000923 Screening Packages for Radioactive Contamination

SOP-000927 Radiation Dosimetry Program

TRNMAT-000013 WEAC Personal Protective Equipment (PPE) 2020

WEAC-TMPL.222 Certification of Hazard Assessment Form for PPE Use

SOP-000178 ORA Shipping

ORA.006 ORA Radiation Safety Manual

S.12 - Special Safety Situations 

S.12.1 - Fire/Explosion Hazards 

Fire and explosion hazards may be a significant concern at many firms. The conditions leading to these 

hazards will usually exist beyond your control. Your safety will depend on your situational awareness 

and prompt action in the event that an emergency arises.

Most firms will be required by state or local authorities to maintain fire detection, alarm, and 

suppression systems. These will usually be similar to the systems you are familiar with from your FDA 

duty station, including alarm pull stations, smoke detectors, and sprinklers. If a firm has properly 

installed and maintained systems, the likelihood of a fire developing before you can evacuate is low. 

Asking the firm’s management or an escorting employee what to do in the event of an alarm should be 

sufficient precaution in most cases.

Firms with very large quantities of flammable chemicals may be required by OSHA to operate under a 

Process Safety Management (PSM) plan. A PSM plan will contain detailed precautions for detecting 

chemical releases and notifying occupants of the need to evacuate. If you suspect the firm may need to 

operate under a PSM plan, discuss the alarms and immediate actions you should take with the firm’s 

management.

If you have doubts about the adequacy of fire detection, alarms, and suppression systems, or if you are 

concerned that the firm does not have adequate plans for a quick evacuation, be alert for signs of 

increased fire risk. An exhaustive list of fire hazards in different industries is beyond the scope of the 

IOM, but some general principles apply universally. 
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Housekeeping practices can be a good indicator of fire risk. Accumulated dust and debris can potentially 

be ignited or contribute fuel to a fire, and disorderly or haphazard storage of materials and equipment 

can obstruct egress routes. Accumulations of grease on surfaces near cooking appliances can increase 

the risk of fire. Haphazardly stored materials are usually easier to ignite than the same materials stored 

in neat, managed stacks. 

Electrical systems are a common ignition source for industrial fires. While it is not possible to assess a 

facility’s electrical systems at a glance, if you notice any evidence of damaged or improvised wiring, 

exposed components or conductors, or heat-damaged building materials, you should consider the area 

to be a fire hazard.

Firms, depending on their types of operations, can be potential sources of explosion hazards. The 

National Electrical Code (NEC) defines hazardous locations as those areas "where fire or explosion 

hazards may exist due to flammable gases or vapors, flammable liquids, combustible dust, or ignitable 

fibers or “flyings."

FLAMMABLE LIQUIDS, GASES OR 

VAPORS

Acetylene, hydrogen, butadiene, ethylene oxide, 

propylene oxide, acrolein, ethylene, cyclopropane, ethyl 

ether, acetone, ammonia, benzene, butane, ethanol, 

gasoline, hexane, methane, methanol, methane, 

naphtha, natural gas, propane, and toluene

COMBUSTIBLE DUSTS

Combustible metal dusts: aluminum, commercial alloys 

and magnesium

Combustible carbonaceous dusts: carbon black, charcoal, 

coal, and coke dusts

Other combustible dusts: Chemicals, flour, grain, plastic, 

and wood

MORE EXAMPLES OF POTENTIAL COMBUSTIBLE DUST 

MATERIALS (OSHA)

AGRICULTURAL CARBONACEOUS METALS

Cellulose Charcoal Aluminum

Corn Coal Iron

Egg white Lampblack Magnesium

Fertilizer Lignite Titanium

Flour Soot Zirconium

Powdered milk OTHERS Zinc

Soy flour Biosolids PLASTIC

Spices Dyes Epoxy resin

Starch Pharmaceuticals Melamine

Sugar Rubber Phenolic resin

Tobacco Soap Polyethylene

Wood flour Sulfur Polypropylene
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OSHA resources on combustible dust include:

• Combustible Dust Explosions Fact Sheet

• Combustible Dust: Protecting Workers from Combustible Dust Explosion Hazards Fact Sheet

Per OSHA, five elements, as indicated below, are necessary to initiate a dust explosion, or what is often 

referred to as the “Dust Explosion Pentagon.” 

• Combustible dust (fuel)

• Ignition source (heat)

• Oxygen in air (oxidizer)

• Dispersion of dust particles in sufficient quantity and concentration

• Confinement of the dust cloud

The first three elements are those needed for a fire and comprise what is commonly known as the “fire 

triangle.” Dispersion of dust particles in sufficient quantity and concentration can cause rapid 

combustion known as a deflagration. If the event is confined by an enclosure such as a building, room, 

vessel, or process equipment, the resulting pressure rise may cause an explosion. Note that if one of the 

five elements is missing, a dust explosion cannot occur.

Precautions for Firefighters to Prevent Dust Explosions - OSHA

An initial (primary) explosion in processing equipment or in an area where fugitive dust has accumulated 

may dislodge more accumulated dust into the air or damage a containment system (such as a duct, 

vessel, or collector). As a result, if ignited, the additional dust dispersed into the air may cause one or 

more secondary explosions. These can be far more destructive than a primary explosion due to the 

increased quantity and concentration of dispersed combustible dust. Many deaths in past incidents, as 

well as other damage, have been caused by secondary explosions.
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S.12.2 - Portable/Personal Electronic Devices (PEDs) 

PEDs, including your mobile telephone, and their chargers, can provide potential ignition sources in 

explosion hazardous atmospheres. They can create electrical sparks, hot surfaces, electrostatic 

discharges, and other potential ignition sources via their batteries, motor brushes, pushbuttons, and/or 

damage caused by impact or related electromagnetic properties. Ignition can occur when the device is 

being used normally, while the device is being charged, or if the device is or has been damaged.

Examples of PEDs include mobile telephones, laptop computers, tablets, cameras, power tools, fitness 

monitors, watches/smart watches, calculators, temperature data loggers, car key fobs, flashlights, 

headlamps, gas monitors, testing equipment, medical devices, and defibrillators. 

Equipment can be designed or modified for safe operation in hazardous locations. There are two general 

approaches for safe operation. One known as intrinsic safety, or non-incendive safety, limits the energy 

present in a device, so that it is insufficient to ignite a hazardous atmosphere under most conditions. 

This includes both low power levels and low stored energy. The second approach, explosion-proof or 

flame-proof equipment, is specifically constructed so that it will not ignite in a hazardous atmosphere, 

including in the presence of any sparks or explosions. Standards have been developed that identify what 

equipment may be used in hazardous locations. The suitability of equipment for specific hazardous 

areas must be tested by a Nationally Recognized Testing Laboratory, such as UL, FM Global, CSA Group, 

or Intertek (ETL).

Note that in the presence of known flammable vapors, OSHA stipulates to use only explosion-proof, selfcontained temporary and portable lights (to include flashlights and headlamps) that have been 

approved for hazardous conditions by a nationally recognized testing laboratory (NRTL). OSHA defines 

such hazardous, flammable conditions as those in which the atmosphere is determined to contain a 

concentration of flammable vapors that are at, or above, 10 percent of the lower explosive limit (LEL), as 

specified in 29 CFR part 1915, subparts B and C.

Consult with your supervisor and/or your IH Contact(s) concerning PED/portable lighting usage and/or 

safety.

S.12.3 - Lithium Batteries 

Per OSHA, small and wearable electronic devices used in workplaces (for example, body cameras) rely 

on a power source that stores a high amount of energy in a small space, in what is often referred to as 

high energy density. Lithium cells provide sustained power and often have the capability to recharge. 

When designed, manufactured, and used properly, lithium batteries are a safe, high energy density 

power source for devices. 

While lithium batteries are normally safe, they may cause injury if they possess design defects, are made 

of low-quality materials, are assembled incorrectly, are used or recharged improperly, or are damaged.

Lithium batteries are generally safe and unlikely to fail-- however, when lithium batteries do fail to 

operate safely or are damaged, they may present a fire and/or explosion hazard. Damage from improper 

use, storage, or charging may also cause lithium batteries to fail.
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OSHA Preventing Fire and/or Explosion Injury from Small and Wearable Lithium Battery Powered 

Devices discusses the specifics of lithium battery-powered devices and their use in hazardous 

atmospheres.

S.12.4 - Confined Spaces 

Referencing Confined Spaces - Overview OSHA: Many workplaces contain areas that are considered 

"confined spaces" because they are not necessarily, or optimally, designed for people, and only large 

enough for workers to enter and perform certain jobs. A confined space also has limited or restricted 

means for entry or exit and is not designed for continuous occupancy. Confined spaces include, but are 

not limited to tanks, vessels, silos, storage bins, hoppers, vaults, pits, manholes, tunnels, equipment 

housings, ductwork, pipelines, etc. 

OSHA uses the term "permit-required confined space" (permit space) to describe a confined space that 

has one or more of the following characteristics: contains or has the potential to contain a hazardous 

atmosphere; contains material that has the potential to engulf an entrant; has walls that converge 

inward, or floors that slope downward and taper into a smaller area, which could trap or asphyxiate an 

entrant; or contains any other recognized safety or health hazard, such as unguarded machinery, 

exposed live wires, or heat stress. Confined spaces shall be identified by the firm who shall then inform

potentially exposed parties of the existence and location of such spaces and their hazards.

Confined Spaces - Standards OSHA addresses specific OSHA standards for general industry, maritime, 

and construction and highlights OSHA standards and documents related to confined spaces.

Confined spaces may be encountered in virtually any occupation; therefore, their recognition is the first 

step in preventing fatalities. Since deaths in confined spaces often occur because the atmosphere is 

oxygen-deficient, toxic, or combustible, confined spaces that contain or have the potential to contain a 

serious atmospheric hazard should be classified as permit-required confined spaces and should be tested 

prior to entry and continually monitored. The references at Confined Spaces - Hazards and Solutions 

OSHA aid in recognizing and evaluating hazards and possible solutions related to confined spaces.

The following is a partial list of examples work areas that are considered to be confined spaces: ship 

cargo holds, import/shipping containers, walk-in freezers, walk-in refrigerators, and walk-in autoclaves. 

Suggested behaviors and actions when encountering potentially confined spaces and situations:

1. Prior to entering a closed area, ascertain if it has been fumigated and, if so, has the space been 

aired out sufficiently. Do not enter if you are uncertain of either condition.

2. When sampling or inspecting at rendering plants or fishmeal plants, be alert to possible hydrogen 

sulfide accumulations in dump pits and other areas. These fumes can be deadly.

3. Be alert and take proper safety precautions in plants, silos, bins, pits, and any closed areas where 

semi-solid buttermilk or other liquid dairy products, silage, or other bulk products are stored. If 

not properly stored, improperly handled, or in a state of decomposition, certain products can 

produce dangerous amounts of carbon dioxide, or other gases, or may deplete the oxygen supply 

in these areas.

4. When transporting dry ice or packages containing dry ice in your car, have some external 

ventilation.
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5. When sampling from the top of a grain elevator, do not jump down, stand on, or walk across the 

top of grain. There may be a cavity caused by crusted grain which could break and result in you 

being buried in grain or being in an atmosphere of fumigating gas.

6. Be alert when entering storage areas having controlled atmospheres, for example, where oxygen 

has been replaced by carbon dioxide to prolong fruit storage, or sulfur dioxide added for 

preservation purposes, etc. These areas should be aerated and deemed safe by the firm prior to 

your entering.

7. Contact your supervisor or IH Contact(s) if you require guidance to determine what hazards or 

DOT regulations may be applicable to a substance when it’s being transported.

8. Be aware that such spaces may not open from the inside and verify that an escape is possible.

S.12.5 - Thermal Processing/Retorts 

Canning retorts are considered confined spaces and are to be regarded as hazardous. 

DO NOT ENTER RETORTS OF ANY KIND UNDER ANY CIRCUMSTANCES. 

Should an inspectional need arise where entering a retort becomes necessary, notify your management 

who will then notify the Program Liaison IH and CFSAN Office of Food Safety’s Division of Food 

Processing Science and Technology. Such inspectional activity occurs on an as-needed, mission-critical

basis ONLY. Retorts should never be entered routinely.

There is the potential to request an employee of the firm to enter the retort on behalf of the agency, 

with an FDA camera and/or equipment and take measurements or photos. Note that such a request is 

not routine; it is completely voluntary, done at the firm’s discretion, and subject to refusal. 

Note that all applicable FDA inspectional forms have been adjusted to eliminate any need for entering

retorts.

S.12.6 Altered/Oxygen-Deficient Atmosphere Environments 

FDA-regulated products are often manufactured and stored using processes that require altered 

atmospheric conditions. Examples include fumigation treatment of food storage areas with pesticides, 

fruit and vegetable ripening rooms, import containers, truck trailers, railroad cars, and device or drug 

processing spaces. Hazards commonly associated with altered atmosphere environments include 

asphyxiation, fires, explosions, and toxic effects. The substance or combinations of substances used to 

alter the atmosphere determine the specific hazards created. Substances commonly used to alter 

atmospheres include nitrogen gas, ozone gas, and fumigants (such as ethylene oxide). 

When interviewing staff at a firm that uses altered atmospheres for processing, gather the following 

information and documents before proceeding with your inspection:

• Safety Data Sheets (SDS) for all substances used to alter the atmosphere. 

• Safety controls used to prevent altered atmosphere exposure and associated hazards. 

• Processes used by the firm to alter the atmosphere.

• Processes by which the firm returns the atmosphere to normal, safe conditions after altering it 

for a process.

• Processes by which the firm verifies that the atmosphere is in a normal, safe condition after 

being altered. 
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• Emergency procedures if someone enters the altered atmosphere environment, or the 

atmosphere is altered while an individual is in a processing space. 

Once the above information has been gathered and you have determined that a risk assessment is 

needed, contact your supervision who can then contact your IH liaison before proceeding with any 

inspectional activities in the affected space(s). Note that altered atmosphere environments are 

commonly associated with confined spaces. Be sure to follow all applicable safety precautions if 

confined spaces are encountered.

S.12.6.1 - Ammonia 

Ammonia is a colorless gas with a distinct odor. It can pose a health hazard because it is corrosive to 

skin, eyes, and lungs. Exposure to 300 parts per million (ppm) is immediately dangerous to life and 

health. Ammonia is also flammable at concentrations of approximately 15% to 28% by volume in air. 

When mixed with lubricating oils, its flammable concentration range is increased. It can explode if 

released in an enclosed space with a source of ignition present, or if a vessel containing anhydrous 

ammonia is exposed to fire. Ammonia spills and releases pose a significant threat to workers from 

skin contact, inhalation, and fire and explosion.

Anhydrous ammonia is widely used as a refrigerant in many industrial facilities, including:

• Meat, poultry, and fish processing facilities

• Dairy and ice cream plants

• Wineries and breweries

• Fruit juice, vegetable juice, and soft drink processing facilities

• Cold storage warehouses

• Other food processing facilities

• Petrochemical facilities

While refrigeration systems are closed systems, ammonia release could occur during receiving, 

storage, or due to leaks. Follow facility safety protocols and in the event of an ammonia leak or 

discharge, immediately evacuate the facility. When conducting field operations due to recalls or 

potential adulteration of product from ammonia, do not enter the facility until, or unless, it has 

been deemed safe to do so. Some inspections may require you to enroll in a Respiratory Protection 

Program for your safety. For example, all investigators conducting egg farm inspections or 

investigations should be medically cleared, fit-tested and trained in the proper use and limitations of 

the issued respirator. You need to determine as much as possible if a chemical hazard, such as 

ammonia, is present at the facility prior to arriving or conducting field work, as applicable. If 

ammonia is identified as a potential hazard, firm management should be asked whether ammonia 

levels are regularly monitored. During egg inspections, for example, you should have your respirator 

with cartridges with you in the event a chemical hazard arises. The hazard of ammonia may also 

need to be considered during other production environments, such as in cheese ripening or aging 

rooms. 

Consult your supervisor or the Safety Liaison for your program or division regarding any inspectional 

safety concerns.

S.12.6.2 - Fumigants and Fumigation 

The use of chemical fumigants for the control of insect infestation can result in hazardous exposures 

to those involved in the handling of both fumigants and fumigated products, like those associated 
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with controlling insects in grains. Fumigants can include pesticides, insecticides, and hazardous 

preservatives. Controlled atmosphere storage of certain food products is also a form of fumigation

where, in a controlled atmosphere, most of the air in an enclosed storage area, or packaging, is 

replaced with a gas such as carbon dioxide.

Fumigant toxic effects can include permanent central nervous system damage, heart and vascular 

disease, lung edema, and cancer.

The increased use of fumigants and increases in the handling of fumigated products, coupled with 

the insidious nature of these toxicants, makes it imperative that you take special care during your 

inspection with respect to fumigated areas and products.

Substances used as fumigants and their usual physical state when applied for that purpose:

Fumigant and Chemical Structure Physical State of Fumigant as it is 

Applied

Acrylonitrile (CH2=CHCN) Liquid

Aluminum phosphide (AlP) Solid

Anhydrous ammonia (NH3) Liquid (gas)

Calcium cyanide (Ca(CN)2) Solid (gas)

Carbon disulfide (CS2) Liquid

Carbon tetrachloride (CCl4) Liquid

Chloroform (CHCl3) Liquid

Chloropicrin (CCl3NO2) Liquid

Cyanogen bromide (BrCN) Liquid

Cyanogen chloride (ClCN) Gas

1,3-Dichloropropene (CHCl=CHCH2Cl) Liquid

Ethylene dichloride (CH2ClCH2Cl) Liquid

Ethylene oxide (CH2 - CH2) Gas

Hydrogen cyanide (HCN) Liquid (gas)

Magnesium phosphide (Mg3P2) Solid

Methylbromide (CH3Br) Gas

Methylene chloride (CH2Cl2) Liquid

Naphthalene (C10H8) Solid

Para-dichlorobenzene (C6H4Cl2) Solid

Phosphine (PH3) Gas

Propylene dichloride (CH2ClCHClCH2) Liquid
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Fumigant and Chemical Structure Physical State of Fumigant as it is 

Applied

Propylene oxide (CH2 - CH-CH3) Gas

Sulfur dioxide (SO2) Gas

Sulfuryl fluoride (SO2F2) Gas

1,1,1-trichloroethane (CH3CCl3) Liquid

Source: American National Standard for respiratory protection during fumigation, ANSI Z88.3-1983

Notes: Aluminum and magnesium phosphide are solid substances that react with moisture to 

produce phosphine gas. At high concentrations, phosphine is spontaneously combustible. Calcium 

cyanide, a solid, reacts with acids to produce HCN, a gas.

Signs shall be clearly posted by the firm in instances where fumigants, pesticides, or hazardous 

preservatives have created a hazardous atmosphere. These signs shall note the danger and specific 

chemical hazards, as well as provide appropriate information and precautions, including instructions 

for the emergency treatment of employees affected by any chemicals in use. In the case of 

containerized shipments of fumigated products, the contents of the container shall be aerated by 

opening the container doors for a period of 48 hours after the completion of fumigation. When 

products are inside or within shipping cases having polyethylene or similar bag liners, the aeration 

period shall be 72 hours. The firm should be able to provide written warranty stating that the 

appropriate aeration period has been met.

S.12.6.2.1 - Fumigant Use by Regulated Firms 

Further references for fumigant use include the 40 CFR 171.2(a)(8) promulgated by the EPA and 

the Agricultural Marketing Service Fumigation Handbook. 

Fumigants present a potential respiratory hazard when used in regulated establishments subject 

to inspection which include, but are not limited to, fumigation or storage facilities where raw 

agricultural commodities (RACs) are encountered, including trucks, vessels, railroad cars, 

shipping containers and fumigation chambers.

Do not enter any structure or conveyance or sample any product that is being treated with the 

fumigants including, specifically, methyl bromide, phosphine or sulfuryl fluoride. If a sampling 

area is suspected of having been fumigated with a fumigant and has not been cleared according 

to EPA requirements, contact your local IH for guidance as to how to ensure that the area is safe 

to enter. Do not enter the area until it is appropriately aerated and tested.

Areas and/or products being treated with fumigants are required by the EPA to be placarded, 

and the placards not to be removed until the treatment is complete (a process usually taking 

from 12 hours to 4 or more days) and the areas and/or products are clear of fumigant gases 

(with, specifically, phosphine at <0.3 ppm and methyl bromide at <1 ppm).

Although there should be no occasion where you should encounter hazardous fumigant 

concentrations, it is advisable to be fully aware of the symptoms of exposure to fumigants. Note 

that, in any situation where exposure to fumigants is unknown/questionable and/or there is 

moderate to high exposure, you should seek medical attention immediately. 

Using phosphine as an example: 

1) Symptoms of exposure to phosphine include: 
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a) Slight or mild poisoning, which may lead to feelings of fatigue, ringing in the ears, 

nausea, pressure in the chest, and uneasiness. All symptoms typically dissipate 

when the person is removed to fresh air. 

b) Moderate exposure, which may lead to general fatigue, nausea, gastrointestinal 

symptoms accompanied by vomiting, stomachache, diarrhea, disturbance of 

equilibrium, strong pains in the chest, and difficulty breathing. 

c) Exposure to very high concentrations, which rapidly causes strong difficulty in 

breathing, bluish-purple skin color, difficulty in walking or reaching, subnormal 

blood oxygen content, unconsciousness, and death. Death can be immediate or may 

be delayed until several days later.

2) Treatment:

a) The EPA-approved label contains information regarding practical treatment regimes. 

If any of the symptoms previously described are experienced, a physician should be 

contacted immediately.

b) To expedite proper treatment, it is advisable to have a copy of the EPA-approved 

label available for the physician. Generally, the most up-to-date information 

regarding medical treatment for exposure is available from the fumigant 

manufacturer. The EPA approved label contains the manufacturer or distributor 

name, address, and phone number. 

S.12.6.2.2 - Fumigants related to Sampling 

When collecting samples that may contain live insects, it may be necessary to fumigate and/or 

preserve the sample. 

As soon as possible, freeze any sample containing, or suspected to contain, live insects—as long 

as freezing will not change or damage the product, or break the container. If freezing is 

inappropriate for maintaining the integrity of the sample, fumigation may be carried out using 

air-tight containers (such as a mason-type jar with inner ring, or a polypropylene container with 

air-tight lid), with sufficient fumigant to kill the insect infestation. 

Moth crystals, containing paradichlorobenzene (PDB), are an alternative fumigant. Do not use 

mothballs or moth flakes containing naphtha or naphthalene. Do not use moth crystals in or 

near plastics, particularly Styrofoam and other polystyrenes as crazing or melting may occur. 

Crazing is the phenomenon that produces a network of fine cracks on the surface of a material, 

for example in a glaze layer. Crazing frequently precedes fracture in some glassy thermoplastic 

polymers. Other alternative fumigants include liquid household ammonia or ethyl acetate--

either of which can be used by dampening on a cotton ball and placing in an appropriate 

container; or by cutting small portions of commercial pesticide strips and placing in container.

Contact your servicing laboratory for guidance on alternative fumigants. 

Follow safety precautions when fumigating and/or preserving samples. Guidance is as follows:

1. Whenever possible, freeze the sample. If freezing is not practical, contact your servicing 

laboratory for alternative fumigants and preservatives.

2. When fumigants or preservatives are used, exercise care to limit your exposure to these 

chemicals. Minimize transfer and exposure time. Avoid getting chemicals on hands or 

clothing. DO NOT MIX CHEMICALS. Contact your ORA Safety staff for the appropriate 

precautions necessary with these chemicals.
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3. Safety Data Sheets (SDS) for each of these chemicals should be available at each duty site 

(for example at, division offices and resident posts), and can also be obtained from the 

chemical manufacturer. These sheets list the hazards involved with these chemicals and 

precautions to take for their use. You should read and follow the instructions in the SDS 

prior to using the chemical. As for shipping, if a measured amount of chemical fumigant 

or preservative is present, and considered a regulated hazardous material, follow the 

guidance and properly ship the item. Again, if you have any questions regarding safety, or 

shipping concerns, contact ORA Safety.

4. Carry all alcohols, fumigants, and other hazardous liquids in approved safety containers. 

5. Ensure DOT regulations and guidance, and International Air Transport Association (IATA) 

guidelines are followed when mailing or shipping samples containing fumigants or 

preservatives. Exceptions for small quantities are listed in 49 CFR 173.4. 

6. The sample identification data on your packaging, the FDA-525 and C/R, must always 

identify the fumigant and method of fumigation, and/or preservative used.

7. SDSs for each chemical fumigant or preservative used must be enclosed with the shipped 

sample. Read and follow all instructions and precautions listed on the SDS.

Additional information on fumigants for preservation can be found at 

• USDA Collecting And Preserving Insects And Mites: Techniques And Tools

• Paradichlorobenzene General Fact Sheet (orst.edu)

• Naphthalene General Fact Sheet (orst.edu)

S.12.6.2.3 - Procedures for Fumigation 

Place a small amount of fumigant, in an airtight container. Separate the fumigant from the 

sample with a piece of paper, paper napkin, or unscented facial tissue. Put specimen or product 

into container and seal tightly. Do not reopen container unless absolutely necessary. If possible, 

use a glass container with a lined screw lid. A mason-type jar with inner ring is also acceptable. 

S.12.6.2.4 - Exceptions to Fumigation 

When submitting samples or exhibits to show live infestation, do not fumigate. Consult with 

your supervisor or your servicing laboratory PRIOR to sending or bringing a live infestation into 

the laboratory to permit preparation for proper handling and storage. Do not fumigate sample 

when submitting samples for pesticide residue analysis.

S.12.6.2.5 - Preservation Liquids 

Insects may be killed and preserved in 70% ethyl alcohol, or a 1:1 mixture of 70% ethyl alcohol 

and glycerin (may be labeled glycerol). These chemicals can be obtained from your servicing 

laboratory. Do not collect rodents or animal tissues unless specifically instructed. Ensure all vials 

or bottles of preservation liquids are tightly sealed to avoid leakage. Identification labels may be 

placed in containers but must be written in India ink or 2H pencil only. Keep all preservation 

liquids away from excessive heat or open flame. 

Identify the preservative used on FDA 525, C/R, and on sample container. Enclose a copy of the 

SDS with the shipped sample. Follow DOT and IATA guidelines when shipping or mailing samples 

with preservatives, as stated under fumigants. 

S.12.6.3 - Ethylene Oxide (EtO) 

EtO is a highly flammable, colorless gas at temperatures above 51.3 oF (10.7 oC) that smells like 

ether (sweet, fruity, pungent) at toxic levels (above 500ppm). EtO is found in the production of 
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solvents, antifreeze, textiles, detergents, adhesives, polyurethane foam, and pharmaceuticals. 

Smaller amounts are present in fumigants, sterilants for spices and cosmetics, as well as during 

hospital sterilization of surgical equipment. Per Ethylene Oxide - Overview OSHA, EtO is produced in 

large volumes and is primarily used as an intermediate in the production of several industrial 

chemicals, the most notable of which is ethylene glycol. It is also used as a fumigant in certain 

agricultural products and as a sterilant for medical equipment and supplies. Unfortunately, EtO 

possesses several physical and health hazards that merit special attention. EtO is both flammable 

and highly reactive. Acute exposures to EtO gas may result in respiratory irritation and lung injury, 

headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis. Chronic exposure has been 

associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, 

and sensitization.

Unmonitored and inadequate ventilation will allow EtO buildup of extremely high concentrations, 

especially in facilities using malfunctioning or leaking equipment. Door gaskets, valves, and threaded 

fittings are typical areas where leaks have been observed. Additionally, exhaust vents from the 

sterilizer and the sterilizer room should not be located near air conditioning intake vents or vented 

directly into work areas. If the odor of EtO is detected, ventilation and containment are evidently 

inadequate. Leave the area and report the situation to your supervisor for further inspectional 

guidance. Special EtO monitoring equipment is available upon request from the Office of Regulatory

Science. 

OSHA standard regulating employee exposure to EtO is presently 1 ppm, over an 8-hour day. You 

should avoid all unnecessary and preventable exposure to it. Adhere to any procedures the firm has 

established for protection of personnel from overexposure to EtO. Where improper venting 

procedures or defective equipment are observed, take adequate precautions, for example, do not 

enter potentially hazardous areas, and/or wear protective clothing and a respirator. 29 CFR 

1910.134 contains basic requirements for proper selection, use, cleaning, and maintenance of 

respirators.

Ethylene Oxide - Hazard Recognition OSHA consolidates references that aid in recognizing and 

evaluating ethylene oxide hazards.

S.12.6.4 - Nitrogen 

Nitrogen gas may be used during product packaging and manufacturing in both food and 

pharmaceutical operations to preserve freshness, prevent microbial growth, and enhance quality by 

preventing the negative impacts of oxygen exposure. Nitrogen flushing is popular for use in food 

packaging because it displaces oxygen, thereby maintaining a long shelf life and preventing spoilage. 

Liquid nitrogen may be used to freeze or cool products during production, and for other processes

including grinding, mixing, and coating. Food firms may use liquid nitrogen in the production of a 

variety of foods, such as meat, poultry, seafood, fruits, vegetables, baked goods, beverages, and 

prepackaged meals. Laboratories requiring specific environments will utilize nitrogen to reduce 

oxygen levels, humidity, and temperature for sensitive procedures and equipment.

Nitrogen is odorless, colorless, and tasteless--attributes accounting for its increased risks in the 

absence of appropriate monitoring. Hazards of nitrogen may include asphyxiation and frostbite. 

While refrigeration systems are closed systems, nitrogen release can occur during receiving, storage, 
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or in instances of leaks. When liquid nitrogen is exposed to the air during leaks, it will evaporate, 

changing from a liquid to an oxygen-depleting gas.

Follow facility safety protocols, and in the event of a nitrogen leak or discharge, immediately 

evacuate the facility. When conducting field operations due to recalls or potential adulteration of 

product from nitrogen, do not enter the facility until, or unless, it has been deemed safe to do so. 

Consult your supervisor or the safety liaison for your program or division regarding any inspectional 

safety concerns.

S.12.6.5 - Ozone 

Ozone is used in many industries during food production, for example, in produce, meat, seafood, 

and water/beverage production; for sanitization purposes; and as a disinfecting agent. Ozone 

gas may be colorless, or appear blue, and has a pungent odor. Exposure to ozone may cause 

headaches, coughing, dry throat, shortness in breath, a heavy feeling in the chest, and fluid in the 

lungs. Respiratory protection may be needed if entering an area with a high concentration of 

ozone. 

S.12.7 - Lockout/Tagout (LOTO) 

The absence of an appropriate Lockout/Tagout (LOTO) method consistently ranks as one of OSHA's most 

frequently cited violations, with the agency citing an average of 120 fatalities and 50,000 injuries each 

year that could otherwise be prevented by instituting/using an LOTO program.

LOTO is used across industries as a safe method of operating, or working on, hazardous equipment. 

Employees servicing or maintaining machines or equipment may be exposed to serious physical harm or 

death if power sources and access/exits to the machinery are not properly controlled. Machine-related 

injuries or fatalities can occur during maintenance and servicing tasks when workers are exposed to an 

uncontrolled release of energy, including during equipment startup, or if faced with an inability to exit, 

due to confined spaces or other factors.

LOTO involves the adoption and implementation of practices and procedures to shut down equipment, 

isolate it from its energy source(s), and prevent the release of potentially hazardous energy while 

maintenance and servicing activities are being performed. LOTO use can apply to any source of electric, 

mechanical, hydraulic, pneumatic, chemical, thermal, or other energy, which, if not controlled, could 

create a hazard. Firms have the flexibility to develop LOTO programs that are suitable for their 

respective facilities.

The following are definitions for Lockout (LO) and Tagout (TO), respectively: 

• LO is a positive means, such as a key or combination-type lock (with a chain as necessary), to 

hold an energy-isolating device in a safe position and prevent energizing a machine or piece of 

equipment.

• TO involves a prominent warning device, such as a tag and a means of attachment, which can be 

securely fastened to an energy-isolating device, according to established procedure. The TO

device shows that the energy-isolating device and the equipment being controlled may not be 

operated until the warning device is removed by the authorized employee who placed the TO

device on the energy-isolating device.
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LOTO ensures that no one can unlock and reenergize a piece of equipment while you are in the 

vicinity of, or in process of inspecting, equipment. LOTO procedures are required if the equipment 

can expose you to the unexpected startup or release of stored energy that could cause injury. For 

FDA, and especially ORA staff, the standard definition of LOTO is expanded well past the “control of 

hazardous energy” to encompass additional potentially harmful situations. Such additional LOTOrelated situations include instances when: 

• You are inspecting machines or equipment on which the guards or other safety devices have 

been removed or bypassed, whether intentionally or accidentally, during cleaning or 

maintenance. 

• Parts or portions of your body are exposed to, or could potentially come within, the danger 

zone associated with the equipment, such as its point of operation. Also known as the 

“working area”, the danger zone is any place in or about a machine or piece of equipment 

where an employee may be struck by or caught between moving parts, caught between 

moving and stationary objects or parts of the machine, caught between the material and a 

moving part of the machine, burned by hot surfaces or exposed to electric shock.

• You need to inspect equipment with entrapment hazards that include walk-in 

freezers/coolers, grain silos, tractor/semi-trailers, import shipping containers, among 

others. 

S.12.8 – Reproductive Hazards and Pregnant Employees 

Where you work, how you work, and what you work with can affect your reproductive health and/or 

your family’s health. OSHA notes that “exposure to reproductive hazards is an increasing health 

concern.” From the Preamble to NIOSH's National Occupational Research Agenda (NORA) Statement on 

Reproductive Hazards: "While more than 1,000 workplace chemicals have shown reproductive effects in 

animals, most have not been studied in humans. In addition, most of the 4 million other chemical 

mixtures in commercial use remain untested. Physical and biological agents that may affect fertility and 

pregnancy outcomes are practically unstudied. The inadequacy of current knowledge coupled with the 

ever-growing variety of workplace exposures pose a potentially serious public health problem." Threequarters of women of reproductive age are in the workforce. Over half of the children born in the 

United States are born to working mothers. See OSHA articles The Effects of Workplace Hazards on 

Female Reproductive Health and The Effects of Workplace Hazards on Male Reproductive Health for 

more information.

Reproductive hazards are substances or agents that may affect the reproductive health of women or 

men or the ability of couples to have healthy children. Hazards may be chemical, physical or biological. 

Examples of reproductive hazards are lead (chemical), radiation (physical) and certain viruses 

(biological). You may be exposed to reproductive hazards by breathing them in (inhalation), by contact 

with skin (dermal) and by swallowing them (ingestion). Potential health effects include infertility, 

miscarriage, birth defects and developmental disorders in children. You can expose your family to these 

hazards by bringing them home from the workplace, for example, on your skin, hair, clothes, shoes, 

tools or car. It is important to prevent these exposures by the use of workplace engineering controls, 

proper work practices and good hygiene.

NIOSH also provides information resources on pregnancy and reproductive health hazards associated 

with workplaces. 
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Per NIOSH, pregnancy can affect your safety as a worker. If you are pregnant, discuss possible job 

hazards with your physician, supervision and your ORA safety office as soon as possible. Many pregnant 

women are able to adjust their job duties temporarily or take extra steps to protect themselves. By law, 

you have the right to receive information on hazards in your workplace and to receive training on how 

to stay safe. See Legal Rights of Pregnant Workers under Federal Law | U.S. Equal Employment 

Opportunity Commission (eeoc.gov) for more information on pregnancy in the workplace.

Pregnant employees should take special note that any and all current occupational exposure limits, 

including those established by OSHA, are set based upon studies of nonpregnant adults. In other words, 

what is considered safe for you, may not be safe for your fetus. Although many employees choose to 

safely continue their jobs throughout pregnancy, pregnancy can sometimes affect worker safety.

If you are pregnant and working, consider the following physiological attributes and/or changes 

experienced during pregnancy that may be in conflict with your usual workplace activities or demands:

• Changes in your metabolism can increase how quickly you absorb some chemicals, including

some potentially hazardous metals. 

• Because of physical changes, the PPE that you wore correctly before pregnancy may no longer

fit properly. This includes lab coats and respirators. Consider refitting and/or acquiring new PPE

as appropriate. Reference Personal protective equipment use while pregnant. 

• Changes in your immune system, lung capacity, and even ligaments can alter your risk of injury 

or illness due to some workplace hazards.

• A fetus might be more vulnerable to some chemicals because of its rapid growth and 

development, particularly early in pregnancy when its organs are developing.

Consult with your physician, your supervisor and/or your IH Contact(s) for further information about any 

reproductive workplace-related health and pregnancy concerns you may have. 

S.13 - Biological Hazards 

Biological hazards may be present during various field investigation and inspection operations. Whether 

you find yourself working in agricultural fields, animal facilities, processing plants, drug, and clinical 

settings, or import operations, you should be cognizant of potential biological hazards and understand 

the appropriate steps needed to mitigate the risks of hazardous exposures. Biological hazards, also 

known as biohazards, are substances of biological origin that pose a health risk or threat to living 

organisms. 

Possible sources of biological hazards vary widely and may include animal and animal products, blood 

and other bodily fluids, and biological waste streams from various processing facilities. Having a better 

understanding of potential biological hazards--through knowledge, appropriate planning, awareness of 

safety practices and preventative medical treatments available (for example, vaccines) can minimize the 

incidence of occupational exposures. Biological hazards may be present while performing work tasks; 

but, regardless of the source, appropriate safety measures can mitigate the risks and limit exposure. 

Appropriate PPE (gloves, N-95 masks, Tyvek protective clothing or coverings, and goggles) can mitigate 

exposure to biological hazards in the environment and are indicated based on the level of hazards 

present and the likely routes of contamination during work activities. Although a comprehensive list of 
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biological hazards is not possible, potential biological hazards and their sources will be addressed in the 

following sections.

S.13.1 - Microorganisms

Microorganisms are a large diverse group of microscopic organisms present in the environment. Only a 

small percentage of the total microorganism population are considered pathogenic, or diseaseproducing, with the capability to infect and negatively impact humans, animals, and plants. Along with 

the capability of producing disease directly, some microorganisms or agents cause additional harm by 

producing secondary products or toxins. 

S.13.2 - Viruses 

Viruses are small infective agents made up of a collection of genetic code (RNA or DNA) that replicate or 

multiply within living host cells. Viruses do not have the capability of replicating on their own but use 

the host cell components to reproduce. Antibiotics are not effective against viral disease. Available 

antiviral medications or vaccines are used to reduce, treat, and manage viral disease. Some examples of 

viral diseases include Human Immunodeficiency Virus (HIV), measles, and COVID-19. 

S.13.3 - Bacteria 

Bacteria are single celled organisms found everywhere on the planet with only a small contingent that 

are pathogenic or capable of causing disease. Bacteria are classified by their basic shape: sphere, rod, 

comma, spiral or corkscrew. Replication of bacteria occurs by binary fission or division with one cell 

dividing into two identical daughter cells. Antibiotics can be effective on specific bacteria, but antibiotic 

resistance may develop over time or under specific conditions. Some bacteria can form dormant 

structures called spores or endospores as a survival mechanism during unfavorable conditions. Spores 

can be very resistant to destruction methods.

S.13.4 - Fungi

Fungi, such as yeasts and molds, are organisms that feed on other organic matter to survive. Fungi are 

similar to plants but are separate as they do not contain chlorophyll and have unique cell wall and 

membrane components. As a group, fungi are very diverse and include molds, yeast, mildews, rusts, 

smuts, and mushrooms. Reproduction of fungi occurs by fragmentation, budding, or the production of 

spores. Some fungi are beneficial and essential to food processes, including for beer, wine, bread, and 

some cheeses. Other fungi can cause harm directly, or by producing a secondary metabolite that can be 

detrimental such as mycotoxins. Mycotoxins, like aflatoxins, are naturally produced, secondary 

metabolites of certain molds capable of causing disease. They can be found on grains, nuts, spices, and 

other food sources. 

S.13.5 - Parasites

Parasites are organisms that live on or within another organism, called the host, often harming it. 

Parasites depend on its host for survival. They can be microscopic (like protozoa) or macroscopic (like 

helminths, or worms and ectoparasites). They can be transmitted through fecal oral route (like protozoa 

and helminths) and affect the gut of the host, by attaching to or burrowing into skin (including 

ectoparasites like mites and lice) or transmitted through insect bites (like protozoa such as plasmodium). 

Food can become contaminated with parasites resulting from the use of contaminated water or 
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improper food handling, and cause infection in consumers who unwittingly ingest such contaminated 

foods. Outdoor environments (including farms, surface water zones and areas, and animal production 

areas) are the most likely sources of parasites. Proper hygiene and PPE can mitigate risks of 

transmission.

S.13.6 - Prions 

Although not a microorganism or living thing, a prion is a protein capable of causing normal proteins in 

the brain to fold abnormally and clump together. These misfolded proteins cause disease by damaging 

the central nervous system and brain tissue. Prion diseases, also known as transmissible spongiform 

encephalopathies (TSEs), impact both humans and animals and can potentially be spread by infected 

animal products, although the nature of the prion transmission is still not well understood. TSEs are

progressive neurodegenerative brain disorders, have long incubation periods, progress rapidly once 

symptoms develop and are always fatal. Bovine spongiform encephalopathy (BSE) is a degenerative 

neurological disorder caused by prions that damages the central nervous system of cattle and is an 

example of a transmissible spongiform encephalopathies (TSEs).

S.13.7 - Biological Allergens 

Biological allergies can result from exposure to certain plants or animal proteins. Some plants can 

produce allergens that cause skin dermatitis, rhinitis, or asthma as a result of exposure pathways of 

direct contact, ingestion or inhalation. Protein allergies from exposure to animal urine, feces, hair, saliva, 

and dander can also cause allergic reactions in sensitized people. 

S.13.8 - Biological Toxins

Biological toxins are hazardous substances produced by microorganisms, animals, insects, and plants 

that can cause harm upon exposure. Depending on the toxin, and amount and route of exposure, health 

effects can range from minor to severe. Toxins may be a secondary product produced by a 

microorganism, such as Clostridium botulinum toxin, or mycotoxins from molds found on such crops and 

food sources as corn and legumes. 

S.13.9 - Routes of Infection/Intoxification 

The routes of infection and intoxication are listed below: 

• Inhalation can lead to infection/intoxification via the respiratory tract, when a person inhales 

aerosols, dust, mists, or vapors containing biological hazards.

• Direct contact can lead to infection/intoxification through contact with broken skin or eyes

(mucous membranes).

• Ingestion can lead to infection via the digestive tract from consuming drinks or food (including 

chewing gum and tobacco) in work areas where hazardous chemicals are present. Poor hygienic 

practices, such as not washing hands after exiting a work area, can also result in the unintended 

ingestion of contaminants when eating, drinking, smoking, or applying makeup. 

• Intoxification occurs when live bacterial cells are ingested which then produce toxins in the 

body.

Adverse health effects will not occur unless infectious or toxic substances enter the body. Common 

routes of entry include inhalation, skin absorption and ingestion; however, entry can occur by more than 

one route. For some pathogens, the symptoms of disease vary based on routes of contamination.
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S.13.10 - Sources of Biological Hazards 

S.13.10.1 - Animals and Animal Origin Products 

Animal biological hazards may be encountered during various field investigation and inspection 

operations, including inspections of animal origin products, inspections of farms and outdoor areas, 

and/or inspections that have pest infestation issues. 

Animals, including insects, can be a source of transmission of biological hazards. Animals have the 

potential to be the direct source of a pathogen, or vector, that transmits the pathogen. When 

around animals, you should take the time and care to understand the possible biological hazards 

that might be present from the animal, or its skin, feces, urine, etc. 

Animal origin products, including foods, may also transmit the same hazards as the originating 

animal; hence the same caution should be taken when handling or manipulating animal origin 

products. Examples of such products include feed, milk, and imported bush meat, as well as 

potentially hazardous handling situations, such as thyroid-processing inspections. The appropriate 

PPE, based on the anticipated hazards of the animal or animal products, should be worn based on 

the exposure risk of the operations involved (see PPE section). When inspecting animal or animal 

origin products, the firm’s safety procedures are to be followed to mitigate exposure risk and 

contamination. If the firm safety measures do not seem adequate for the situation, have a 

discussion with your supervisor and the program IH. 

S.13.10.2 - Rodent-Infested Areas - Hantavirus 

Hantaviruses are a group of viruses primarily spread by rodents that can cause disease in humans. 

Hantavirus can be spread to humans through aerosolization of virus shed in rodent feces, urine, 

saliva, and, less frequently, from an infected animal bite. 

If inspecting crawlspaces, sheds, or warehouses, there is the potential for you to encounter 

biological hazards associated with rodents and other small animals. Although the exposure risk is 

low in most cases, evaluation of the potential exposure and risk should be taken along with any 

precautions, like use of PPE, needed when entering these areas. 

When encountering known or suspected rodent-infested areas, the following protective and 

preventive measures should be implemented: 

• Avoid direct contact with rodents dead or alive. Limit your exposure to rodent feces, urine, 

etc. 

• Avoid, as much as possible, moving items around in dusty areas to limit the aerosolization of 

particulates when inspecting crawlspaces, sheds, or warehouses, and when performing 

necessary field exams and during breakdown of dusty pallets. If aerosolization of 

particulates is unavoidable, wear appropriate PPE.

• Wear appropriate PPE for the associated risk, which may include gloves, coveralls, eye 

protection, and a respirator, depending on the potential hazards and risks. 

• Use good hygiene practices. Avoid touching your face, mouth, or eyes with potentially 

contaminated gloves. After removing gloves, wash hands with soap and water thoroughly. 
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• Follow any specific guidance issued by federal, state or local health departments on 

hantavirus in the area or locality in which you are working. 

S.13.10.3 - Poultry Houses

You may be exposed to biological hazards when entering poultry houses such as zoonotic diseases 

including Salmonellosis, Campylobacteriosis, Chlamydiosis, Tuberculosis, Newcastle Disease, and 

Avian Influenza that may be present in the facility. Influenza and tetanus vaccinations are 

recommended for these inspections. Additionally, appropriate PPE is necessary to prevent personal 

exposure to potential biological hazards when entering these types of facilities. PPE is also used for 

biosecurity measures, and to prevent the transference of biological hazards between houses and 

locations. PPE for poultry and egg houses typically includes Tyvek coveralls, boot covers, eye 

protection, gloves, hair nets, and a respirator, but be sure to follow specific program guidance. 

Other safety hazards can also be associated with poultry and egg houses (see the physical hazard

and chemical hazard safety sections). 

S.13.10.4 - Animal Feed 

The Bovine Spongiform Encephalopathy (BSE) inspection and feed testing program investigators 

have the potential to encounter BSE-infected products during animal feed truck inspections and 

product sampling. Appropriate PPE for such tasks includes gloves and a respirator, which should be 

worn if there is potential for the animal feed particulate to become aerosolized, or airborne, during 

inspection and sampling operations. 

S.13.10.5 - Sub-human Primate and Animal Testing Facility Hazards

During inspections or investigations of sub-human primate facilities (for example, Good Laboratory 

Practice (GLP) inspections, non-clinical laboratory testing facilities, animal holding facilities, etc.), do 

not enter rooms housing any sub-human primates. Monkeys housed in these facilities have the 

potential to carry Herpes-B Virus (also known as B virus, Simian B Virus, Herpes B, herpesvirus 

simiae, herpesvirus B, monkey B virus or monkey virus). B virus infection can lead to severe brain 

damage or death if you do not get treatment immediately. Be sure to follow the firm’s safety 

protocols, including recommended use of any PPE. 

During inspections of this type, you are not to enter any rooms which hold or house sub-human 

primates. Bioresearch monitoring (BIMO) inspection information should be obtained from firm 

personnel interviews and record evaluations. Review of study records is to be completed outside of 

the primate housing areas. Information on animal room activities is to be obtained through firm 

personnel interviews. 

In addition to your IH, consult the references below for animal exposure situations: 

• OSH Animal Safety

• Occupational Health and Safety in the Care and Use of Nonhuman Primates

• Occupational Health and Safety in the Care and Use of Research Animals
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S.13.10.6 - Plants and Plant Products

S.13.10.6.1 - Psyllium

Psyllium is a type of soluble dietary fiber that can generate an allergic reaction in some sensitive 

individuals. Psyllium production facilities may require additional safety measures prior to 

entering their facilities. Allergen pretesting may be needed, including a radioimmune assay 

(RAST) blood test, prior to entry. Follow the safety guidance for the manufacturing facility and 

according to the relevant ORA Safety Grab and Go document. 

S.13.10.7 – Human Biologics (Blood, Tissue, Plasma and Other Bodily Fluids)

Blood banks and plasma inspections pose the potential for exposure to blood and other bodily 

fluids. Investigators should be cautious and take suitable precautions to prevent infection in firms

such as tissue and blood banks or other places where they may be subject to contact with infectious 

substances. Blood and tissues should be considered potentially infectious and capable of 

transmitting disease, including HIV and hepatitis. Follow all PPE protocol and precautions as 

determined by the risk evaluation for the job task. 

Bloodborne Pathogens (BBP) are infectious microorganisms carried in blood and Other Potentially 

Infectious Materials (OPIM) that when transmitted from an infected individual can cause disease. 

Exposure to BBP can occur across a variety of situations, with exposure potentially occurring 

through sharps, including needle sticks, via broken skin and also mucous membranes. The 

pathogens of primary concern are hepatitis B (HBV), hepatitis C (HCV), and HIV that causes acquired 

immunodeficiency syndrome (AIDS). Other bloodborne pathogens exist too and are covered by the

OSHA Bloodborne Pathogen (BBP) Standard. The OLS and OHS provide a Bloodborne Pathogen 

Exposure Control Plan (BBPECP), with an HBV vaccine available to individuals who work with, or who 

may be potentially exposed to BBPs on the job. The FDA Bloodborne Pathogens Exposure Control 

Plan is for employees who may encounter blood (human or animal) or Other Potentially Infectious 

Materials (OPIM). The plan complies with OSHA’s Bloodborne Pathogens Standard and is designed 

to guide workers on how to identify and minimize risks associated with exposure to bloodborne 

pathogens or OPIM.

S.13.10.8 - Biohazardous Waste

Waste streams have the potential to be contaminated with biological hazards. Biohazardous waste 

or infectious waste shall be treated in accordance with federal, state, and local regulations, and be 

handled and disposed of properly. Disposal of biohazardous waste is often conducted through a 

regulated waste vendor or contract service. Biohazardous waste types you may encounter during 

investigations, include sharps, infectious waste, and solid waste, all of which has the potential to 

transmit disease. 

S.13.10.9 - Processing Facilities

Various facility processes have the potential to increase the generation of aerosols-- including filling, 

blending, grinding, spinning, pressurized rinsing, extruding, and spraying—all of which can increase 

the risk of transmission of biological hazards by inhalation and/or distribution of potential hazards 

through exposed contact surfaces. 
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An increase in biological hazards can occur during the processing of raw animal products, the 

processing of toxin-producing organisms themselves (mycotoxin on corn), or processing that 

propagates or use a biological hazard (vaccine manufacturers). 

Although food can be contaminated with pathogens indirectly by contaminated water, animal 

intrusion, or improper food handling, levels are not expected to be high enough to present a high 

risk of transmission during sample collection at food processing plants. Additional information on 

hazards associated with foods can be found in Potential Hazards for Foods and Processes.

Processing and manufacturing facilities typically have safety controls and procedures in place to 

mitigate exposure to the possible hazards during production, including biological hazards. Follow 

IOM protocol and discuss facility safety measures with firm personnel prior to visiting the site when 

possible, or when on location. You should follow the firm’s procedures for mitigating exposure risks 

during an inspection, to include any administrative, engineering, or PPE controls. PPE may include 

gloves, face shields, eye protection, coveralls, booties, and appropriate respirators for the specific 

hazards. 

S.13.10.9.1 - Precautions - Blood and Plasma Inspections 

Be alert around blood banks or blood-processing operations to the possible dangers of 

infectious agents.

Keep in mind the following:

1. Do not handle lab instruments, blood samples, containers, or reagents in blood bank 

labs unless absolutely necessary. Wear lab coats with long sleeves. Disposable lab coats 

that are impervious to blood are an optimal choice. Upon completion, such coats should 

be left in the laboratory area to be disposed of at the facility. 

2. Do not smoke, drink, eat, or meet in blood banks, or in testing areas for Hepatitis B 

Surface Antigen (HBsAg), HIV, or any other infectious agents.

3. Do consider blood samples, antigens, and antigen testing kits, and other associated HIV-, 

HBsAg-, and other test reagents as potentially infectious.

4. Do consider the possibility of aerosol contamination if there is spilling or splashing of 

test reagents or blood samples.

5. Use care when placing inspectional or personal equipment in any lab or testing areas.

Wash hands thoroughly after these inspections. Hepatitis can be transmitted by hand to 

mouth.

6. Use disposable gloves. Spills may be adequately addressed by wiping with a 5% sodium 

hypochlorite solution, and/or solutions such as Wescodyne or Betadine. Autoclaving is 

the preferred method (121 degrees C for 60 minutes) for sterilizing reagents, samples, 

and equipment. Note: When accidental spills or similar incidents occur in your presence, 

you are not required to participate in cleaning or disposing of materials. These activities 

are the firm's responsibility.

7. Use scrupulous adherence to standard/universal personal hygiene practices at all times 

in the blood bank, and in the testing areas for HBsAg, HIV, and other infectious agents.
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S.14 - Chemical Hazards 

The following basic information and steps can assist you in recognizing hazardous chemicals, thus 

enabling you to anticipate potential exposures, and follow preventive measures and practices when 

preparing for and during site visits. Research any prior inspection histories (file jacket, OSAR, FACTS...)

and the type of trade or commodity to be inspected to gain knowledge about the type of chemicals you

may encounter in establishment you will be visiting. You may also consult with your supervisor and the 

program’s IH Contact(s) for guidance. In addition, while on site, you should also have access to and the 

opportunity to review information on chemicals that are present, including SDSs and labeling systems. 

The following paragraphs provide an overview of the health and physical hazards posed by some 

chemicals, as well as reliable sources of information that can be used as reference: 

Hazardous chemicals are substances that have the potential to cause harm to human or animal health, 

the environment, or are capable of damaging property. Chemical hazards can be present and in facilities 

of the industries that we regulate. Chemical hazards can be in solid, liquid, or gas form. Some are safer 

than others; but to some workers, who are more sensitive to chemicals, even common forms can cause 

illness, skin irritation, or breathing problems. You can even experience chemical exposures without 

direct handling of substances or products. Chemicals can be toxic, corrosive, flammable, and/or

combustible. As such, they can pose health risks to workers and become hazards if inhaled, ingested, or 

absorbed through the skin. Chemical hazards can cause acute harm, such as burns, irritation, and 

vomiting--or create chronic, long-term health issues, such as asthma, liver damage, and cancer. 

Identifying potential and actual hazards and taking proper precautions to minimize the hazard(s) and 

protect yourself is key to avoiding any health problems or complications. 

Employers in the United States are required by law to assess the hazards posed by the chemicals present 

in their workplaces and to implement measures to protect personnel from exposure to those hazardous 

chemicals. However, some unforeseen incidents, such as equipment failures, or accidental spills or 

releases may occur, thus increasing the possibility of exposures. While some chemicals have evident 

warning properties, such as a pungent odor at low or harmless concentrations that helps facilitate their 

detection, others have no detectable warning properties at all and require monitoring instruments to 

detect and measure their concentrations in air to determine if levels are safe. Awareness of the 

properties and hazards posed by chemicals present aid personnel in taking appropriate action to stay 

safe while performing tasks at different worksites. 

Due to the nature of ORA’s field investigations and the industries we regulate, there may be situations in 

which you may or may not anticipate, or be aware of chemical hazards, until you are in the field. The 

following information provides a guide to some common chemical hazards but is not all inclusive. It is 

recommended that you conduct a brief chemical hazard assessment with the regulated firm upon your 

arrival to ensure your personal safety. This may be as simple as asking the firm representative, during 

the opening discussion, if there are any known chemical hazards within the facility. Firm management is 

often aware of the chemical hazards that exist at their facility and will have safety guidelines and 

procedures that you will be expected to follow. If you determine that there is a chemical hazard, and 

you are unsure, or concerned, about the effectiveness of the firm’s control of the hazard or your ability 

to minimize your exposure to the hazard through the use of physical separation and/or PPE, contact 
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your supervisor and consult with your Program’s IH Contact(s) for guidance. If in any doubt about your 

safety, you should leave the area until all of your concerns have been resolved.

For any known chemical hazards that you identify prior to going out to conduct the inspection (based on 

your knowledge of the regulated commodity, pre-inspectional web searches, previous Establishment 

Inspection Report, etc.), be sure to also look through the available “Grab and Go Safety Guidance” tools

that have been developed and/or posted on the ORA Safety SharePoint page available to all ORA 

employees. 

S.14.1 - Chemical Hazard Basics 

S.14.1.1 - Routes of entry for Chemical hazards 

In order to cause health problems, chemicals must enter your body. There are three main “routes of 

exposure,” or ways by which a chemical can enter your body. Common routes of entry include 

inhalation, skin absorption, and ingestion; however, entry can occur by more than one route. 

• Inhalation happens when absorption occurs through the respiratory tract. 

• Direct contact happens when absorption or injections occur through the skin, mucous 

membranes or eyes. 

• Ingestion happens when absorption occurs through the digestive tract. 

S.14.1.1.1 - Inhalation 

Through inhalation of vapors, fumes, mists, aerosols, or dusts, the breathed chemical enters the 

bloodstream though the lungs. Once in the bloodstream, chemicals may then be carried 

throughout the body and affect other organs. 

S.14.1.1.2 - Skin Absorption 

Skin (or dermal) absorption is another route of entry that may cause localized effects, such as 

irritation or damage of the tissue in direct contact with the hazardous chemical. Absorption can 

also lead to other responses, such as sensitization and systemic effects. If chemical sensitization 

occurs, subsequent skin exposures to that chemical may lead to allergic reactions in the skin or 

even at sites remote from the skin, such as the respiratory tract. 

S.14.1.1.3 Ingestion 

Another route of exposure is ingestion (or oral), which may happen when drinking or eating 

food, or notably, chewing gum or tobacco in work areas where hazardous chemicals are present. 

Poor hygienic practices can also contribute to chemical ingestion exposure.

S.14.2 Chemical Health Hazards 

The following table from OSHA’s Hazard Communication - Guidance For Hazard Determination further 

identifies chemical hazard categories:

CHEMICAL PHYSICAL HAZARDS

Fire Hazards

Combustible liquid

Flammable liquid

Flammable aerosol

Flammable gas

Reactive Hazards

Organic peroxide

Unstable (reactive)

Water-reactive

Explosion Hazards

Compressed gas

Explosive
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Flammable solid

Oxidizer

Pyrophoric

CHEMICAL HEALTH HAZARDS

Systemic Effects

Carcinogen

Toxic agent

Highly toxic agent

Corrosive

Irritant

Sensitizer

Target Organ Effects

Hepatotoxin

Nephrotoxin

Neurotoxin

Blood/hematopoietic toxin

Respiratory toxin

Reproductive toxin

Cutaneous hazard

Eye hazard

OTHER IMPORTANT CHEMICAL HEALTH HAZARDS

Cardiovascular toxicity

Gastrointestinal toxicity

Immunotoxicity

Skeletal/muscular effects

Connective tissue effects

Endocrine system toxicity

Sensory organ toxicity (sight, hearing, taste)

S.14.2.1 – Toxicity 

Toxic chemicals may enter the body through any route of exposure and cause significant health 

effects at different levels.

• Acute toxicity. Substances with high acute toxicity may be fatal or cause damage to target 

organs (organ in the body that is most affected by the specific chemical, drug, bacteria, or 

other substance) as a result of a single exposure, or exposures of short duration. Examples 

of substances with high acute toxicity include hydrogen cyanide and hydrogen sulfide.

• Reproductive toxicity. Chemicals that cause adverse effects on any aspect of human 

reproduction, including the impairment of male or female reproductive organs, fertility, and

fetal development.

• Specific target organ toxicity (can occur via single or repeated/prolonged exposure). 

Chemicals that can significantly impair the function of a target organ system after either a 

single or repeated exposure. Effects may be reversible, or irreversible, and can be 

immediate or delayed.

S.14.2.2 - Corrosives / Irritants (Skin, Eye, Respiratory) 

Corrosive substances have the ability to cause visible destruction or irreversible alterations in living 

tissues by chemical action at the site of contact. Irritants can generate reversible damage upon 

contact, affecting skin, eyes, and respiratory tract. 
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S.14.2.3 - Sensitization (Skin, Respiratory) 

A sensitizer is a chemical that causes a substantial proportion of exposed people or animals to 

develop an allergic reaction in normal tissue after repeated exposure to the chemical.

S.14.2.4 - Germ Cell Mutagenicity 

Mutagens are chemicals that can modify the genetic material in the nucleus of cells in ways that 

allow the changes to be transmitted during cell division. Some mutations may result in cell death or 

the transmission of a genetic defect to other cells in the same tissue.

S.14.2.5 - Carcinogenicity 

Carcinogens are substances capable of inducing or causing cancer or malignant tumor development, 

typically after repeated or chronic exposure. Carcinogens may cause no immediate harmful effects 

and may only become evident after a long latency period. Many factors influence the development 

of cancer, including the carcinogenic potency of the substance, the level and duration of exposure, 

and individual susceptibility to the carcinogenic action of the substance. 

Entities, including the National Toxicology Program (NTP) and the International Agency for Research 

on Cancer (IARC) classify carcinogens after an extensive scientific review process. OSHA, NTP, and 

IARC all provide lists of specific substances identified as carcinogens.

In addition to chemicals, infectious agents--such as viruses, toxins, and physical agents, such as Xrays and ultraviolet radiation--may be classified as carcinogens.

S.14.2.6 - Aspiration Hazards 

Aspiration hazards are substances that have the potential to enter the trachea and lower respiratory 

system through the oral or nasal cavity during inspiration, or breathing, in causing asphyxiation, 

injury, or other negative health effects. The hazard relates to the possibility of lung damage after 

swallowing the product. There are different categories of aspiration hazards, ranked according to 

their level of toxicity. Essential oils sometimes have an aspiration toxicity hazard, which is common 

for low-viscosity hydrocarbon substances. 

S.14.2.7 - Simple Asphyxiants 

Simple asphyxiants are inert gases or vapors that can displace oxygen in ambient air when they 

become too concentrated. Inhaling ambient air with an oxygen level below 19.5% will cause 

inadequate oxygen supply to blood and organs within minutes after the exposure. Depending on the 

severity of the oxygen deficiency, the exposed person may experience symptoms including impaired 

attention, thinking or coordination; fatigue; nausea; vomiting; lethargy; loss of consciousness; and 

death. Symptoms may appear suddenly, and damage caused by lack of oxygen may be irreversible.

Some examples of simple asphyxiants include nitrogen, helium, neon, argon, krypton, xenon, 

methane, and ethane. Since these colorless and odorless gases offer no detectable warning 

properties, oxygen monitors are often used to verify oxygen levels in processes involving the use of 

these substances. 

Another type of asphyxiant, chemical asphyxiants, can cause suffocation by either preventing the 

uptake of oxygen in the blood, or by preventing the normal oxygen transfer from the blood to the 
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tissues or within the cell itself. Examples of these chemical asphyxiants include hydrogen cyanide 

and carbon monoxide.

Oxygen levels can also be consumed/reduced/displaced by rusting metals, ripening fruits, the drying 

of paints and coatings, combustion, and bacterial activities.

S.14.3 - Chemical Physical Hazards 

OSHA states that a chemical is a physical hazard if it is likely to burn or support fire; may explode or 

release high pressures that can inflict bodily injury; or can spontaneously react on its own, or when 

exposed to water. OSHA Appendix B to 1910.1200 lists the physical hazards and definitions that will be 

discussed in this section. Appendix B also contains more detailed information on each physical hazard, if 

needed.

S.14.3.1 - Corrosive to Metals 

A chemical that is corrosive to metals is a chemical that will materially damage or destroy metals by 

causing a chemical reaction.

S.14.3.2 - Explosives 

An explosive substance (or mixture) is a solid or liquid that is, in and of itself, capable (by chemical 

reaction) of producing gas at such a temperature and pressure, and at such a speed as to cause 

damage to its surroundings. Pyrotechnic substances are included in this category even when they do 

not involve gases. A pyrotechnic substance (or mixture) is designed to produce an effect by heat, 

light, sound, gas, or smoke--or a combination of these as the result of non-detonative, selfsustaining, exothermic chemical reactions.

If you suspect a chemical could be potentially shock-sensitive and/or explosive, do not move the 

container in which it is found or held. Movement of containers containing potentially unstable 

chemicals could cause an explosion due to shock, heat, and friction sensitivity. Furthermore, be on 

the lookout for the following warning signs associated with potentially unstable chemicals that could 

lead to an explosion: deterioration of the chemical’s container, crystal growth on the inside or 

outside of the chemical’s container, and/or discoloration of the chemical itself.

S.14.3.3 - Flammables and Combustibles 

Flammable and combustible materials come in many forms, including gas, liquid, solid, and aerosol. 

These types of materials are associated with two main hazards: fires and explosions.

• Flammable Gases are flammable in air at 68°F and at a standard pressure of 101.3 kPa (14.7 

psi).

• Flammable Liquids have a flash point of not more than 199.4°F. Substances and mixtures of 

this hazard class are assigned to one of four hazard categories based on their specific flash 

point. 

• Flammable Solids are readily combustible or may cause or contribute to fire through 

friction. 

• Flammable Aerosols are aerosols that contain any component classified as flammable 

according to the criteria for flammable liquids, flammable gases, or flammable solids. 
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• Readily Combustible Solids are powdered, granular, or pasty substances that are dangerous 

as they can be easily ignited if exposed to an ignition source--such as a burning match--and 

the flames will spread rapidly. 

S.14.3.4 - Self-reactive Chemicals 

Self-reactive chemicals are inherently unstable and susceptible to rapid decomposition, and/or can 

react alone in a violent, uncontrolled manner. This definition excludes chemicals classified as 

explosives, organic peroxides, oxidizing liquids, or oxidizing solids. They are thermally unstable 

liquids, or solids, liable to undergo a strongly exothermic thermal decomposition, even in the 

absence of oxygen (air).

S.14.3.5 - Pyrophoric (liquids or solids) 

Pyrophoric liquids or solids are liable to ignite within five minutes after coming into contact with air, 

even if present in small quantities.

S.14.3.6 - Self-heating substances 

A self-heating chemical is a solid or liquid chemical--other than a pyrophoric liquid or solid-- which, 

by reaction with air and without energy supply, is liable to self-heat. This chemical type differs from 

a pyrophoric liquid or solid in that it will ignite only when in large amounts (kilograms) and after long 

periods of time (hours or days). Self-heating of a substance or mixture is a process in which the 

gradual reaction of that substance, or mixture with oxygen (in air), generates heat.

S.14.3.7 - Water-reactive materials 

Water-reactive materials emit flammable gases when in contact with water. They are solid or liquid 

chemicals which, by interaction with water, are liable to become spontaneously flammable, or to 

give off flammable gases in dangerous quantities.

 S.14.3.8 - Oxidizers (liquid, solid or gas) 

Oxidizers are chemicals or materials that have the ability to oxidize other substances, or, technically 

speaking, accept another substance’s oxygen electrons. Oxidizers pose a safety concern due to their 

potential to promote and enhance fires. Fires need fuel, oxygen, and ignition sources. Oxidizers 

supply the oxygen, and, as a result, can facilitate burning or make fires burn hotter and longer. 

Special precautions should be taken around oxidizers in which visible crystalline growth or 

discoloration of the chemical is observed or noted. Common oxidizing agents include

• Oxygen

• Ozone

• Hydrogen peroxide and other inorganic peroxides, Fenton's reagent

• Fluorine, chlorine, and other halogens

• Nitric acid and nitrate compounds such as potassium nitrate, the oxidizer in black powder

• Potassium chlorate

• Sulfuric acid

• Peroxydisulfuric acid

• Peroxymonosulfuric acid
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• Hypochlorite, chlorite, chlorate, perchlorate, and other analogous halogen compounds like 

household bleach

• Hexavalent chromium compounds such as chromic and dichromic acids and chromium 

trioxide, pyridinium chlorochromate (PCC), and chromate/dichromate compounds such as 

Sodium dichromat

• Permanganate compounds such as potassium permanganate

• Sodium perborate

• Nitrous oxide, Nitrogen dioxide/Dinitrogen tetroxide

• Sodium bismuthate

• Cerium (IV) compounds such as ceric ammonium nitrate and ceric sulfate

• Lead dioxide

S.14.3.9 - Gases Under pressure 

Gases under pressure are gases that are contained in a receptacle at a pressure not less than 200 

kPa (29 psi) or are gases that are liquefied or refrigerated. This covers four types of gases, or 

gaseous mixtures, to address the effects of sudden release of pressure or freezing which may result 

in serious damage to people, property, or the environment, independent of other hazards the gases 

may pose. The four types of gases under pressure are compressed gases, liquefied gases, 

refrigerated liquified gases, and dissolved gases.

S.14.3.10 - Organic Peroxides 

An organic peroxide is any organic (or carbon-containing) compound having two oxygen atoms 

joined together (-O-O-). Organic peroxides are thermally unstable chemicals that may undergo 

exothermic self-accelerating decomposition. In addition, they may have one or more of the 

following properties:

• Be liable to explosive decomposition. 

• Burn rapidly. 

• Be sensitive to impact or friction. 

• React dangerously with other substances.

Given their instability, organic peroxides can rapidly decompose, leading to flammable vapors that 

can easily catch fire and burn intensely. This is due to the peroxides providing both the fuel and 

oxygen needed for the fire. Some chemicals become explosive peroxides during storage, further

enhanced in their explosiveness by exposure to light and heat. Others become more dangerous as 

they are concentrated. 

The plastics and rubber industries are the largest users of organic peroxides. They are used as 

accelerators, catalysts, hardeners, activators, and more.

S.14.4 - Additional Chemical Hazard Information/Resources 

OSHA’s Hazard Communication Standards webpage highlights OSHA standards, preambles to final rules 

(background to final rules), directives (instructions for compliance officers), and standard interpretations 

(official letters of interpretation of the standards) related to hazard communication including: 

General Industry (29 CFR 1910) 

• 1910 Subpart Z, Toxic and hazardous substances

• 1910.1200, Hazard communication

o Appendix A, Health Hazard Criteria
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o Appendix B, Physical Criteria

o Appendix C, Allocation Of Label Elements

o Appendix D, Safety Data Sheets

o Appendix E, Definition of "Trade Secret"

o Appendix F, Guidance for Hazard Classifications Re: Carcinogenicity

• 1910.1201, Retention of DOT markings, placards and labels

OSHA’s HAZARD COMMUNICATION: Hazard Classification Guidance for Manufacturers, Importers, and 

Employers provides guidance on the processes involved and identifies considerations in the conduct of 

hazard classifications. Guidance on the allocation of the hazard communication label elements is 

provided in the OSHA Brief on Labels and Pictograms, located on the Hazard Communication webpage.

Under the Hazard Communication Standard (29CFR1910.1200) established by OSHA, chemical 

manufacturers and importers are required to perform hazard classifications on the chemicals they 

produce or import. That information is available in SDS, formerly known as MSDSs, that employers are 

required to have readily available for review for each one of the chemicals present at their worksites. In 

general, SDSs provides information on the hazards of the product--including the physical and chemical 

properties, toxicology, handling and storage guidance, exposure controls, recommended PPE, first aid,

firefighting and accidental release measures and any other applicable information. SDSs have sixteen 

sections; carefully review sections 2 and 4 as the substance’s hazards and first aid measures are listed 

under these two sections. SDSs can also easily be located online.

Labels and pictograms also aid in communicating chemical hazards information to personnel sharing the 

work environment.

The OSHA Occupational Chemical Database is OSHA's one-stop shop for occupational chemical 

information. It compiles information from several government agencies and organizations. Information 

available on the pages includes:

• Chemical identification and physical properties. 

• Exposure limits. 

• Sampling information. 

• Additional resources. 

S.14.4.1 - Chemical Labeling 

When evaluating chemical hazards, review the chemical SDSs and any precautionary labeling. When 

conducting inspections of firms using chemicals, like pesticides, ask to review the SDSs for the 

products involved to determine what, if any, safety precautions you should take. This could include 

the use of respirators or other safety equipment. 

Sometimes, products encountered during field activities fall under alternate labeling requirements 

than cited references. For example, pesticides, food additives, and food and drug/cosmetic 

ingredients, and their facilities, may use specific databases for confidentiality reasons. Regardless of 

any alternate labeling systems, the hazard information should always be disclosed to you. 

Terminology and standards may vary by country or region. If there is any confusion, contact your 

supervisor before entering potentially hazardous areas. If safety procedures at a foreign firm are 

inadequate for your protection, take precautions based on your training and experience with 

domestic activities. If you have any doubts about your safety at a foreign worksite, you should 
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immediately move to a safe location, suspend the inspection as necessary, and contact your 

supervisor(s) for guidance.

Also review any precautionary labeling, such as Globally Harmonized System of Classification and 

Labeling of Chemicals (GHS), which is available. The primary purpose of GHS labels is 

to communicate chemical hazards to workers, or recipients, through signal words, pictograms, 

hazard statements, and precautionary statements.

OHSA maintains a section on its website with more in-depth information on GHS labeling and 

classification at: https://www.osha.gov/hazcom. The following, however, provides you with a basic 

description and pictogram of each of the nine GHS label chemical hazard classifications.

CORROSION

Health hazards: Skin Corrosion/Burns, Eye Damage, 

and other hazards.

Corrosives are highly reactive substances that 

cause obvious damage to living tissue. Corrosives 

can either directly destroy the tissue or indirectly 

by causing inflammation. They can also be 

corrosive to metals.

EXCLAMATION 

MARK

Health hazards: Irritant (skin and eye), Skin 

Sensitizer, Acute Toxicity (harmful), Narcotic 

Effects, Respiratory Tract Irritant, Hazardous to 

Ozone Layer (Non-Mandatory). 

Chemicals or materials that can cause an 

immediate skin, eye or respiratory tract irritant, or 

narcotic

EXPLODING BOMB

Explosives, Self-Reactives, Organic Peroxides – 

Chemicals or materials that are highly unstable and 

at high risk of exploring even without exposure to 

air. A peroxide is a substance in which two oxygen 

atoms are linked together by a single covalent 

bond. This bond makes these peroxides capable of 

causing a severe fire or explosion hazard

FLAME

Flammables, Pyrophorics, Self-Heating, Emits 

Flammable Gas, Self-Reactives, Organic Peroxides - 

Chemicals or materials that can self-ignite when 

exposed to water or air, or which emit flammable 

gas. Pyrophoric refers to the property of a 

substance to ignite spontaneously upon exposure 

to air
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FLAME OVER CIRCLE

Oxidizers - Chemicals or materials that have the 

ability to oxidize other substances, that is, they 

accept their oxygen electrons. As a result, these 

chemicals can facilitate burning or can make fires 

burn hotter and longer

GAS CYLINDER

Health hazards: Gas cylinders have numerous 

hazards ranging from direct or indirect exposure 

from the chemical gas itself, fire or explosion as the 

gas is under high pressure, and even trauma from 

improper handling such as sprains, strains, falls, 

bruises, or broken bones.

Gases Under Pressure – Chemical gases that are 

stored under pressure, such as ammonia or liquid 

nitrogen. 

HEALTH HAZARD

Health hazards: Carcinogens are substances known 

to cause cancer. Mutagens are substances known 

to cause or increase the rate of changes to genes 

(sections of DNA in body’s cells), these changes can 

be passed along as the cell replicates. Sensitizers 

are substances known to cause an allergic reaction 

in normal tissue upon exposure.

Carcinogen, Mutagenicity, Reproductive Toxicity, 

Respiratory Sensitizer, Target Organ Toxicity, 

Aspiration Toxicity – Chemicals or materials that 

cause damage over time (a chronic, long-term 

health hazard).

SKULL AND 

CROSSBONES

Health hazards: Acute Toxicity (fatal or toxic) -

Chemicals or materials that have an immediate and 

sever toxic effect. Acute toxicity describes the 

adverse effects from a single exposure to a 

substance. These adverse effects can come from 

either oral (mouth) or dermal (skin) contact from a 

single dose of a substance, or multiple doses within 

a short period of time (24 hours), or inhalation 

exposure (4 hours)
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ENVIRONMENT 

(NON-MANDATORY)

Aquatic Toxicity - Chemicals or materials that are 

toxic to aquatic wildlife

S.14.4.1.1 - Resources related to Hazard Communication (HAZCOM)/chemical labeling 

• OSHA Hazard Communication Publications

• OSHA Labels and Pictograms

• OSHA Hazard Communication Wallet Card

• 33 Hazard Classes | Postal Explorer (usps.com)

• US Department of Transportation Nine Classes of Hazardous Materials

S.14.5 – Special Chemical Hazards 

*Please note that this list is provided for your awareness and does not include every chemical hazard 

that you may encounter while working in the field. Be prepared to assess the chemical hazards on-site, 

ask questions of firm management, and consult with your supervisor and your IH Contact(s) for guidance 

to determine if you need to take additional precautions to protect yourself.

S.14.5.1 - Allergens/Hypersensitivities 

Food allergies and food hypersensitivities occur when the body's immune system reacts to certain 

proteins in food. Food allergic reactions vary in severity from mild symptoms, including hives and lip 

swelling to severe, life-threatening symptoms, often called anaphylaxis, that may involve fatal 

respiratory problems and shock. In 2004, the U.S. Congress passed the Food Allergen Labeling and 

Consumer Protection Act (FALCPA), which identifies eight foods as major food allergens: milk, eggs, 

fish, shellfish, tree nuts, peanuts, wheat, and soy. On April 23, 2021, the Food Allergy Safety, 

Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the ninth 

major food allergen recognized by the United States. More than 160 foods have been identified to 

cause food allergies in sensitive individuals. There are also several food ingredients that cause 

nonallergic hypersensitivity reactions in sensitive individuals. These ingredients include, but are not 

limited to, gluten, colorings, and food additives.

If you or a team member has an allergy or hypersensitivity to the commodity, or something related 

to the processing of the commodity, to be inspected, remember that your personal safety comes 

first. Consult with your supervisor about the potential to reassign the inspectional work, or to 

discuss the appropriate precautions to be taken. When discussing appropriate precautions, consider 

consulting with the Safety Liaison for your program or office. 

S.14.5.2 - Animal Food Ingredients 

Most animal food manufacturing establishments are no more unsafe than most human food 

manufacturing establishments. Many of the relevant safety hazards are addressed in this section, 
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and include chemicals, allergens, fumigants, and confined spaces. Some feed manufacturers may 

have Type A medicated articles and/or concentrated minerals in their inventory to be used in 

manufacturing, so if you intend to sample or otherwise handle those materials, please read the label 

and observe any safe handling precautions.

If you are going to be conducting an inspection at a facility that manufactures Type A medicated 

articles, concentrated minerals (such as copper or selenium premix), or other specialty feed 

ingredients, it is helpful to know those substances in advance, so that you can be sure to have the 

appropriate PPE with you. You may need to wear a smock, dust mask, and gloves if you need to 

handle the materials (if you are sampling, for example). Feed manufacturing facilities may also be 

dusty, so if you are sensitive to dust, you may wish to wear a dust mask. Unless you are allergic to 

the chemicals present, a respirator should not be necessary, but if you think you would require one, 

consult with your supervisor and IH liaisons. Wash hands and other exposed skin when you are 

done. 

Biosecurity is also important. Do not travel from an animal production facility or farm to a feed 

manufacturing facility on the same day, or in the same clothes or PPE, so as not to introduce hazards 

into any facility.

For any related questions or concerns, contact CVMAnimalFoodProgram@FDA.hhs.gov prior to 

conducting an inspection.

S.14.5.3 - Dry Ice- Transport and Use for Shipping Samples 

Dry ice is potentially dangerous and requires caution in handling and shipping. Dry ice can cause cold 

burns and frostbite. Be sure to protect yourself by using the appropriate PPE, including safety 

goggles to protect your eyes from splashes; a face shield to protect sensitive tissues such as your 

mouth, nose, and other facial areas; and gloves to protect your hands (which should fit loosely so 

that they can be easily removed). When handling dry ice, also ensure that all other skin is covered 

with proper attire and that you wear closed toed shoes. 

Dry ice can also contribute to an asphyxiation hazard. Dry ice should be stored and handled in wellventilated areas. Dry ice should not be stored in sealed containers to prevent the risk of explosion.

Do not handle with unprotected hands, transport in your car without adequate ventilation, or place 

inside tightly closed metal, plastic, or similar type containers that do not breathe. If it is necessary to 

use this type of container, adequately vent it to prevent pressure buildup. Do not use glass 

containers for packaging or storing dry ice. Again, make note that a failure to adequately vent a 

container containing dry ice may cause a dangerous pressure build-up, resulting in serious risks to 

sample integrity and the personal safety of all those handling the container). 

When shipping frozen samples using dry ice, packages shall be identified in accordance with CFR 49, 

the International Air Transport Association (IATA) Dangerous Goods regulations and the UPS 

Dangerous Goods Agreement and Checklist. See IOM 4.7.3.5.1 when shipping packages containing 

dry ice.

Any FDA employee who ships items subject to Department of Transportation’s (DOT) hazardous 

materials regulations must complete Shipping Dangerous Goods Safety Training. 
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S.14.5.4 - Opioids 

Opioids are substances derived from the opioid poppy or manufactured synthetic analogues. When 

conducting opioid sampling, adequate safety precautions should be observed during the sampling 

process. Do not handle opioids, including fentanyl and fentanyl analogues, without appropriate 

PPE, which may include nitrile gloves, coveralls, goggles, and a respirator, depending on the 

situation and exposure risk. Possible routes of opioid exposure may include inhalation, ingestion, 

and dermal contact. Opioids have the potential to be inhaled in situations where drug samples are 

disturbed, and particles have become airborne. Avoid tasks that may aerosolize fentanyl or other 

opioids. Change gloves if they become contaminated. Avoid contact with eyes, mouth, nose, or 

unprotected skin with contaminated gloves. Wash hands with soap and water immediately after 

sampling, or as soon as feasible. Do NOT use alcohol-based hand sanitizers to clean contaminated 

skin as these products could increase the drug absorption. 

Opioid overdose symptoms include respiratory distress with slow, shallow breathing, small 

constricted “pinpoint” pupils, confusion, drowsiness, nausea and vomiting, and loss of 

consciousness. The opioid antidote medication Naloxone (Narcan) nasal spray can reverse the 

effects of opioid overdose and restore normal breathing. Naloxone (Narcan) training is available for 

individuals at risk for exposure to opioids. Contact a supervisor or industrial hygienist for training 

information. Additional information can be found at Preventing Occupational Exposure to Fentanyl | 

NIOSH | CDC and Fentanyl: Incapacitating Agent | NIOSH | CDC (includes PPE recommendations).

*Special and similar safety considerations should also be made for firms responsible for penicillin

antibiotics, dietary supplements, and CBD products. 

S.15 - Physical and Radiation Hazards 

Conditions at a firm may present a risk of injury to ORA investigators. This section covers situations or 

conditions that may cause traumatic injuries, and physical agents, such as noise and radiation (ionizing 

and non-ionizing), that may lead to certain occupational illnesses. It will focus on specific topics that you

should be vigilant about before and during a site visit.

Physical hazards are factors within the environment that can harm the body. Physical hazards include 

activities or natural substances in a work environment that pose health risks. Extreme temperatures, 

poor air quality, and excessive noise and radiation can all harm workers, potentially causing respiratory 

problems, hearing loss, and cancer, among other problems. This category also includes traumatic 

injuries, which are the most common physical hazards. Physical hazards are present in most workplaces, 

at one time or another, and include unsafe conditions that can cause immediate and acute injury, 

illness, or death.

S.15.1 - Traumatic Injury Hazards/Industrial Injuries and Energy Related 

Illnesses 

S.15.1.1 - General Environmental Conditions 

The OSH Act requires employers to comply with hazard-specific safety and health standards. In 

addition, pursuant to Section 5(a)(1) of the OSH Act, employers shall provide their employees with a 

workplace free from recognized hazards likely to cause death or serious physical harm.
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In some circumstances, heat or cold stress could be considered conditions that require training and 

other mitigation actions to be implemented. ORA Safety can be contacted if you have concerns 

regarding heat or cold stress. Temperature extremes can adversely impact the investigation process 

and put you at risk for heat or cold stress injuries. If you anticipate hot and/or humid conditions due 

to either the geographic location or the type of industry, attempt to staff the inspection team with 

members who are acclimated to similar conditions if possible. Inspections in potential heat stress 

conditions should be conducted by a team of two or more, with members observing each other for 

any signs of heat-related illnesses. If you anticipate significant exposure to cold conditions, prepare 

for the inspection by wearing suitably insulated clothing, or bringing appropriate PPE. In situations 

of extreme heat or cold, it may be necessary to plan work schedules to minimize the length of 

exposure. Information on temperature-related injuries and illnesses can be found on the ORA Safety 

SharePoint Online site.

Poor lighting can increase the risk of injury due to other causes, for example, by making it difficult to 

see tripping hazards. It may be possible in some cases to request a firm turn on additional lighting, 

or to wait for a time of day when natural lighting is better; but most likely the best solution will be 

using flashlights or other portable lighting.

Moving work surfaces, for example conveyor belts, can increase the likelihood of slip/trip/fall 

injuries or of striking/being struck by objects. Options for mitigating these increased risks may be 

limited. Supervisors should avoid assigning these inspections to individuals with medical conditions 

that may impair balance or equilibrium. Motion sickness may also be a concern. You should discuss 

potential working conditions with the firm and ask for the same advice that would be given to a new 

employee at the firm. FDA’s Occupational Health Service (OHS) may be able to provide consultation 

and prescriptions to help deal with motion sickness for sensitive individuals.

S.15.1.2 - Slips, Trips and Falls 

Fall hazards can be related to floor conditions, as well as elevated walking surfaces. Poor floor 

conditions can put you at risk for slipping or tripping. Slipping results from not having enough 

traction between footwear and the floor surface, while tripping results from either too much friction 

or uneven surfaces. Common slipping hazards in industrial facilities include ice, highly polished or 

worn floors, or fine powders on the floor. Under good lighting, any of these hazards are generally

easy to spot, but it can be easy to overlook changes in floor conditions when moving from one area 

of a firm to another, especially in poor light conditions. For example, entering cold storage areas 

may put you at risk for slipping on icy or slushy floors. Similarly, tripping hazards due to slight 

changes in floor level are common where buildings have been added or extended over the years.

A fall from any height can cause injury, but federal safety regulations require protection at heights 

of 48 inches or more. The most common practice in industry is to install standard guard rails where 

a fall of 48 inches or more is possible, or where a shorter fall would result in exposure to a hazard 

below, such as landing on machinery. Standard guard rails in industrial facilities exist as they do in

most other buildings, with a top rail that is roughly at waist height for most adults, and an 

intermediate rail halfway between the top rail and the floor. Avoid moving closely to ledges that are 

not guarded by a substantial rail, and remain at least far enough away that slipping, tripping, or 

being bumped or knocked into would not put you at the edge.
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Some firms use personal fall restraint or fall arrest systems near unguarded ledges. Fall restraint 

systems use a belt or harness attached to a short lanyard, generally preventing workers from getting

close enough to the edge to fall off. A fall arrest system uses a harness and shock-absorbing lanyard 

that will decelerate should a worker fall, bringing them to a stop before reaching the floor. Note that 

a successful fall arrest is still likely to result in injuries but reduces the chances of more significant 

ones. Fall restraint and arrest systems require careful fitting and significant training to use safely. Do 

not use fall restraint or fall arrest systems provided by a firm. If you are in a situation in which such 

a system seems to be the optimal, or only, option for completing an inspection, contact your 

supervisor and seek advice from your supporting Industrial Hygienist.

S.15.1.2.1 - Manlifts 

A manlift is a device consisting of a power-driven, endless belt moving in one direction only, 

outfitted with steps or platforms and attached handholds, for the transportation of personnel 

from floor to floor.

Do not ride on a rotating belt, manlift style elevator at any time. 

S.15.1.2.2 - Aerial Work Platforms 

Many firms have aerial work platforms, mobile aerial devices, or bucket trucks to provide 

temporary access to elevated areas of a facility. The major causes of injuries and fatalities 

involving aerial lifts are falls, electrocutions, and collapses or tip-overs. Aerial devices include 

boom-supported aerial platforms, such as cherry pickers or bucket trucks, aerial ladders, and 

vertical towers. (Note that OSHA regulates scissor lifts as mobile scaffolds, not as aerial devices). 

Do not operate or ride in firm aerial work platforms. Specific operational and safety training is 

required to utilize the equipment. If you are in a situation in which it appears necessary to use 

such a platform to complete an inspection, contact your supervisor and seek guidance from your 

supporting IH.

S.15.1.2.3 - Non-Permanent Scaffolding 

A scaffold is an elevated, temporary work platform. There are two basic types of scaffolds:

• Supported scaffolds, which consist of one or more platforms supported by rigid, loadbearing members, such as poles, legs, frames, outriggers, etc.

• Suspended scaffolds, which are one or more platforms suspended by ropes or other 

nonrigid, overhead support.

Note that other types of equipment, principally scissor lifts and aerial lifts, can be regarded as 

other types of supported scaffolds.

Potential injuries associated with all scaffolds:

• Falls from elevation, due to lack of fall protection.

• Injuries due to collapse of the scaffold, caused by instability or overloading.

• Injury as a result of being struck by tools, work materials, or debris that have fallen from 

the scaffold. 

• Electrocution, due to the proximity of the scaffold to overhead power lines.

Do not stand on non-permanent scaffolding at any time. 

S.15.1.2.4 - Ladders 

Per OSHA Fact Sheet on Fall Protection Standards: Falls from ladders account for 20 percent of 

all fatal and lost work-day injuries in general industry. In general, ladders must be capable of 

supporting their maximum intended load, while mobile ladder stands and platforms must be 
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capable of supporting four times their maximum intended load. Each ladder must be inspected 

before initial use in a work shift to identify defects that could cause injury.

Fixed Ladders – Fixed ladders are permanently attached to a structure, building, or equipment. 

These include individual-rung ladders, but not ship stairs, step bolts, or manhole steps. New 

OSHA rules have phased in a requirement for employers to have ladder safety or personal fall 

arrest systems for fixed ladders that extend more than 24 feet, phasing out the use of cages or 

wells for fall protection.

Portable Ladders – Portable ladders usually consist of side rails joined at intervals by steps, 

rungs, or cleats. They can be self-supporting or lean against a supporting structure. Firms must 

ensure that:

• Rungs and steps are slip-resistant.

• Portable ladders used on slippery surfaces are secured and stabilized.

• Portable ladders are not moved, shifted, or extended while a worker is on them.

• Top steps and caps of stepladders are not used as steps.

• Ladders are not fastened together to provide added length, unless designed for such 

use.

• Ladders are not placed on boxes, barrels, or other unstable bases to obtain added 

height.

If you find it unavoidable to use a ladder, follow OSHA Ladder Safety, including the following 

guidelines:

• Inspect the ladder being used/provided by the firm. If the ladder provided by the firm is 

not in good repair, ask the firm for another ladder.

• As available, read and follow any manufacturer’s labels or markings on the ladder,

including the maximum load rating.

• Do not use ladders that are damaged or in disrepair.

• Do not use makeshift ladders, or ladders that are positioned on top of boxes or unstable 

bases.

• Always maintain a three-point contact with the ladder when climbing.

• If possible, avoid carrying supplies or materials in your hands while climbing a ladder.

• Do not stand on the top rung unless it is designed for that purpose.

• If using a ladder, follow a 4:1 ratio for maintaining the proper angle of a ladder--that is, 

for every four feet of ladder height up to where the ladder rests on a surface, position 

the ladder base one foot away from the wall, with three feet extending beyond the 

upper landing surface.

• Do not overextend the ladder.

• Have someone hold the ladder while you are using it.

• If collecting samples while on a ladder, extreme care should be taken to not overreach, 

or lean too far beyond the center of the ladder and increase the risk of falling. 

S.15.1.2.5 - Overhead Hazards 

Overhead hazards are defined as hazards located above you that you may come in contact with

or that can fall on you. They also include hazards associated with work activities that require you 

to do something above your head. Some overhead hazards include dropped objects, powerlines, 

and flying/fixed objects.
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You should never walk under a suspended or elevated load. Avoid walking under powerlines if 

possible. Work conducted in areas with overhead hazards should be limited to only what is 

necessary. Proper head protection should be worn at all times.

S.15.1.2.6 - Machinery Hazards 

You will encounter a variety of machinery types during your inspectional activities. Per OSHA, 

each piece of machinery has its own unique mechanical and nonmechanical hazards. Machines 

can cause severe injuries, such as amputations, fractures, lacerations, or crushing injuries. 

Machines can also cause minor injuries, such as bruises, abrasions, sprains, strains, burns, or 

cuts. 

Examples of mechanical hazards that can hit, grab, or trap are: 

• Hazardous motions. 

• Points of operation. 

• Pinch points and shear points. 

There are different types of hazardous mechanical motions and actions: 

• Hazardous motions such as rotating parts, reciprocating parts, or traversing parts. 

• Hazardous actions such as cutting, punching, shearing or bending. 

Nonmechanical Hazards can also injure operators, or those nearby, and include flying chips, 

splashes, or sprays that are created when a machine is running.

Normal practice in industry is to enclose, or guard, any moving parts or pinch points on 

machinery that could strike, entrap, or otherwise injure workers. Typically, such practice is

required for any point of operation hazards within seven feet of the floor or other walking 

surface. Do not assume the machine guarding meets an OSHA standard. Extreme care should

be taken when working in or around moving parts of equipment.

S.15.1.3 - Energy Hazards 

Energy sources, including electrical, mechanical, hydraulic, pneumatic, chemical, nuclear, thermal, 

gravitational, or other sources in machines and equipment, can be hazardous. Be aware of the 

potential for any of these types of energy hazards.

S.15.1.3.1- Thermal Energy 

Thermal energy occurs when heat or cold is produced by mechanical devices (combustion 

and/or friction), electrical resistance, or chemical reactions (or changes of state like cryogenic 

materials). Boiling water is an example of thermal energy. Burns can occur due to both cold and 

hot forms of thermal energy, with the severity of the burn dependent on temperature and 

duration, or contact.

S.15.1.3.2 - Residual Energy 

Residual or stored energy is energy within the system not being used, but when released, can 

cause severe injuries, even though equipment has been turned off or locked out.

S.15.1.3.3 - Electrical Energy 

Electrical energy is the most commonly identified form of energy in workplaces. It can be 

available through power lines, induced, or stored, for example, in batteries or capacitors. 
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S.15.1.3.3.1 - Electrical Systems 

Many inspectional activities are performed in poorly lit areas, or in older, poorly wired 

buildings. Be alert for low hanging wires, or bare, exposed, or worn wires, and broken or 

cracked electrical outlets.

When you are using portable power tools, etc., be extra cautious of the shock hazard. See 

Inspection Technical Guide # 22, Ground Fault Circuit Interrupter | FDA, regarding Ground 

Fault Circuit Interrupters. Use one if feasible.

S.15.1.4 - Powered Industrial Vehicles 

S.15.1.4.1 - Forklifts 

Forklifts are powerful vehicles commonly used for lifting and moving heavy loads. Some of the 

most common forklift accidents include overturns, being struck by a forklift, and falls from a 

forklift. You are not to operate a forklift as specialized training is required. 

Accidents/injuries can be the result of forklifts and pedestrians traveling or moving in the same 

area. Forklift traffic should be separated from pedestrians wherever possible. Be aware of and 

stay within any floor markings, walkways, or aisles that delineate where you should be walking

or that separate pedestrians from forklift and other vehicle traffic. 

Additional forklift safety/vehicle reminders:

• Be aware that vehicles cannot stop suddenly. They are designed to stop slowly, to 

minimize load damage and maintain stability.

• Stand clear of vehicles in operation, including lifting and moving loads. 

• Avoid a run-in. The driver's visibility may be limited due to blind spots.

• Be aware of the vehicle’s wide, rear-swing radius.

• Never pass under an elevated load.

S.15.1.4.2 - Moving Cranes 

Moving cranes are used for lifting and moving heavy loads; but, unlike a forklift, the load is 

suspended overhead from a cable attached to the crane. Both the crane and the load attached 

can pose a serious hazard. Ensure you maintain a safe distance from the crane in the event that 

the crane/load tips or shifts. 

S.15.1.4.3 - Mobile Elevated Work Platform (MEWP) 

A MEWP, also known as a cherry picker, is a movable platform to help with high-level access 

tasks. Due to the heights involved, a serious fall or electrocution from a MEWP may be fatal. 

Due to the specialized training to operate this vehicle, consult with your supervisor and the ORA 

Safety Office before entering the basket of this type of vehicle. 

S.15.1.4.4 - Semi Trucks 

Semi-trucks and attached trailers have larger blind spots and require extra space to maneuver. 

Loading docks, where semi-trucks pickup or drop, are frequent locations of accidents due to 

these blind spots. As with any type of moving vehicle, maintain a safe distance from any moving 

semi-trucks.
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You may be required to enter the trailer or take a sample from the top of the trailer. Prior to 

any activities inside or from the top of a trailer, ensure the truck is properly blocked in a way to 

prevent anyone from moving the truck while you are in or around it. Also ensure that you 

cannot be trapped or locked inside a trailer, via LOTO, or with the aid of another person. 

Take frequent breaks if you are entering a trailer in hot weather. 

If you take samples from the top of the semi-trailer, ensure proper safety precautions for 

climbing ladders. Never enter a trailer from the top.

S.15.2 - Radiation Hazards 

Potential exposure to radiation can be found in nearly every ORA program because many FDA-regulated 

facilities use or manufacture radiation-emitting electronic products, including laser products, x-rays used 

in medical devices and blood banks, radioactive material used in positron emission tomography, and 

radiopharmaceuticals. Additionally, import and domestic inspectors may be asked to collect FDAregulated products that possess potential radioactive contamination. Portable instrumentation used by 

ORA inspectors may also have an associated radiation hazard, including handheld or benchtop chemical 

analyzers.

Below is a brief overview of these hazards. For a full list of up-to-date radiation safety resources, 

including, but not limited to training requirements and contacts, visit ORA Radiation and Laser Safety 

Resources. 

S.15.2.1 - Examinations with Non-Ionizing Radiation Hazards 

Equipment that produces non-ionizing radiation can be found in nearly any inspection. Typical nonionizing radiation encountered includes lasers, radiofrequency waves, microwaves, and ultraviolet 

light. Protective eyewear and other equipment for non-ionizing radiation must be provided by the 

manufacturer. If you see signs or placards indicating the presence of non-ionizing radiation hazards

(for example, a sign marked “Laser Area”) do not enter the area unless provided with proper 

protective equipment. 

If you believe there is a non-ionizing radiation hazard and you have not been given PPE by the firm, 

either do not enter the area, or tell a representative from the firm to power-off all equipment 

producing non-ionizing radiation hazards before continuing. 

S.15.2.2 - Examinations with Ionizing Radiation Hazards 

ORA strives to limit exposures to the Nuclear Regulatory Commission’s (NRC’s) public limit and 

considers 99% of the ORA inspectorate as non-radiation workers. ORA issues radiation dosimeters, 

radiation pagers, and radiation awareness summaries to employees engaged in the following 

activities or assignments:

• Operations involving an XRF analyzer.

• Import examinations. CBP also utilizes some radiation-based technologies to screen 

incoming shipments. 

• Positron emission tomography inspections.

• Radiography x-ray inspections.

• Radiopharmaceutical inspections.
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• Fluoroscopy inspections.

• Mammography inspections.

• Computed tomography inspections.

• Sterility facility inspections.

• Blood bank facility inspections.

• Imports/domestics (in cases of radiologically contaminated products).

Dosimeter Monitors are assigned to individuals by ORA Program Management, who are responsible 

for distributing and collecting dosimeters at the end of each wear period. For an updated list of 

dosimeter monitors, see the ORA Radiation and Laser Safety Resources SharePoint Site. 

It is important to keep in mind that dosimeters only record radiation exposures, which can only be

discovered after a potential radiation exposure event has occurred. Radiation Pagers, on the other 

hand, will warn an inspector of dangerous radiation while in the field, in-situ. If a Radiation Pager 

alarms, immediately leave the area. See Radiation Awareness for Dosimetry and Pager Users. 

Upon inspecting a facility that contains ionizing radiation, ORA employees should expect to be given a 

firm-issued dosimeter, or other device, to measure radiation exposure. Per NRC and Agreement State 

regulations, visitors to facilities are considered members of the general public. If you do not receive 

any equipment from the firm, proceed with caution.

S.15.2.2.1 - When to stop examinations/collections due to Ionizing Radiation Hazards 

If you encounter any of the following situations during an inspection, stop work immediately 

and contact your supervisor(s):

• Radiation levels above the general public limit (as alerted via pager alarms).

• The use of any uncontained, volatile, or loose radioactive material. 

• Collection of radioactive samples that cause pager to alarm above public limit. 

• Collection of radioactive samples that are powdery or volatile.

Individuals assigned to these duties are considered radiation workers. In addition to completing 

awareness training and carrying a dosimeter and pager, these individuals must complete 

hands-on classroom radiation safety and advanced equipment training approved by the ORA

health physicist (HP). 

S.15.2.3 - Radioactive Product Sampling 

Sampling of potentially contaminated FDA-regulated products from all FDA programs could result in 

potential internal and external exposures to ionizing radiation. Safety equipment required for 

working around these products includes radiation dosimeters and radiation pagers. Sampling of 

volatile or powdery material containing radioactive particles requires special training. Air monitors 

or use of respirators may also be required. DOT and IATA regulations pertain to shipping radioactive 

samples. Contact Supporting IH and ORA HP for details at ORA Radiation and Laser Safety Resources 

SharePoint Site. 

S.15.2.3.1 - Sampling Instrumentation with Radiation Hazards 

The following handheld and benchtop instruments have been issued to ORA inspectors 

encountering radiation hazards: 

• X-ray fluorescence Spectrometer for external ionizing radiation hazards.

• Ion Mobility Spectrometer for potential contamination hazards.

• Raman Spectrometer for laser hazards to the eyes. 
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S.15.3 - Animal Hazards 

Inspections, particularly of farms and outdoor operations, have the potential to have animals and insects 

present. 

As an investigator, you may encounter domesticated animals such as, dogs, cats, cattle, horses, 

chickens, sheep, etc., as well as wild animals, such as foxes, coyotes, badgers, wolverines, martens, 

rodents, spiders, and snakes, etc., during farm and outdoor operations. Be aware that any animal 

species can be dangerous, depending on circumstances. You may also experience infectious disease 

transmission from mosquitoes and ticks, small animal bites and swelling, or mild to severe allergic 

reactions from stinging insects. 

Animal behavior can be unpredictable; you should remain constantly alert and watch for warning signs 

of animal aggressiveness and fear. These vary with animal breeds, but may include raised fur, flattened 

ears, twitching tails, or bared teeth. If a potentially hazardous encounter occurs, you should make no 

attempt at engaging with the animal and instead should vacate the area immediately and notify firm 

management as necessary. 

Wear appropriate clothing for the situation. Wear long pants and sleeves, and boots taller than the 

ankle, as appropriate for the inspection and area. Use insect repellant. Stay out of tall grass and keep 

hands and feet out of areas you cannot directly see. If an encounter with an animal occurs in which you 

are injured, including a snake/spider/dog bite, seek emergency help immediately. 

For snake bites, responding quickly is crucial. Immediately call for emergency medical attention. While 

waiting for emergency help to arrive, wash the area with soap and water if possible and apply a cold 

compress. Keep the bitten area lower than the heart and remove any constricting clothing and jewelry 

from the extremity as the area may swell. Note the time and location of the bite to report to emergency 

room personnel. Try to remain calm while waiting for help to arrive. 

S.15.3.1 - Dog bites/attacks 

If you are going to be conducting an inspection or investigation where you may encounter dogs--

such as, but not limited to, the private residence of an individual, a shell egg producer, farm facility, 

or warehouse--you should exercise caution. If the inspection or investigation will be pre-announced, 

ask if there are farm or guard dogs on the property, and if so, whether they will be leashed or 

kenneled before your scheduled arrival. If the inspection will not be pre-announced, observe the 

area carefully prior to exiting your vehicle. Be aware of common places that dogs may hide, 

including under parked cars and hedges, or on porches. Upon exiting the vehicle, be aware of your 

surroundings to see if any noises from the vehicle, shutting doors, etc., have aroused the attention 

of a dog on the property. If an employee is present on the property, ask if any dogs are present. If 

you are entering a fenced-in area, rattle the gate before entering to alert animals to your presence 

and reduce chances of conflict. If you are bitten by a dog, seek medical care and report the incident 

to your supervisor. For additional information, refer to: 

• ORA ORS Dog Encounters Grab and Go

• Dog bite prevention | American Veterinary Medical Association (avma.org)

• Dog Bite Prevention | ASPCA

• Dog Attack Information for All Mail Carriers (usps.com)
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• Be Aware: Any Dog Can Bite - Postal Posts (uspsblog.com)

• 'Watch That Dog' explains basic protection and provides insight into the mannerisms of 

various types of dogs. This video from the Oregon OSHA Workplace Education and Training 

Grant Program https://osha.oregon.gov, tells how to protect yourself from possible attack 

and injury.

S.15.4 - Specific Industries 

S.15.4.1 - Grain Handling Facilities 

Grain storage structures, such as grain elevators and feed mills, can present life-threatening hazards. 

It is always preferable to inspect them or collect samples from the outside. If it is not possible to 

collect the samples from the outside, consult your supervisor prior to collection. 

Before entering a grain storage structure, be sure to: 

• Meet with the facility’s operator to discuss hazards that may be present in the storage 

structure, including entrapment or engulfment in grain, asphyxiation, or the presence of 

toxic or flammable atmospheres, as well as procedures to be followed in the event of an 

emergency. 

• Confirm that the operator will lock out any moving equipment within the storage structure, 

such as conveyors and augers, and will conduct atmospheric tests for oxygen, combustible 

gases and toxic gases. Contact your supervisor for any questions. 

• Refer to Man Lifts and Ladders for guidance. Do not use a man lift without supervisory

approval. 

• Make sure cross-rungs on ladders are safe. 

• When stepping off of ladders or man lifts, be sure the floor is a true floor and not a bin 

covered with canvas, cardboard, or other temporary non-supportive cover. 

• Never stand or walk across the surface of the material stored in a silo. The surface may only 

be a “thin crust” over a hollow space in the silo. Breakthrough the crust often causes death 

by engulfment of the material and subsequent asphyxiation. 

• Make sure walkways between bins are sturdy. 

• Use caution when sampling from high bins or tanks. Wet or icy conditions may prevail, so 

check these conditions. 

• When brass grain bombs are used to collect bin samples, do not drop the bomb to the 

surface of the grain. This activity could cause sparks if the bomb hits the bottom or side of a 

bin. Instead, lower the bomb gently to the grain surface, then raise it four to five feet and let 

it fall to the grain surface to collect the sample. Do not use steel grain bombs; use only brass 

bombs for sampling. 

• Do not use flash units in dusty areas because of the possibility of explosion hazards. Any 

electrical devices used, including flashlights, cell phones, communication radios, and similar 

devices, should be explosion-proof. 

• Do not enter a grain storage structure without appropriate PPE, or if you see that any grain 

is frozen or caked to the walls. Wear PPE during inspection and sampling, including for bump 

caps.
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S.15.4.2 - Rail Safety 

S.15.4.2.1 - Railyards 

Railyards are dangerous areas. If there is a Safety Office at the yard, inquire about specific 

information concerning current hazards.

Maintain a safe distance from equipment in motion and cross tracks at right angles, whenever 

possible, without stepping on rails. Be aware of the pressure wave created as a train (or any 

moving vehicle) passes. This force can knock people down and into the path of subsequent cars. 

S.15.4.2.2 - Railcars 

When sampling railcars, make sure doors are propped open to avoid accidental closing if the car 

is bumped while you are in it. Display a warning flag or similar device to alert others that you 

are in the car. Always have a railroad yardman or another FDA investigator present. When 

entering the car, make sure the ladder is secure. On hot days, or after a car has been fumigated, 

it should be aired out prior to entering, preferably by opening both doors. Observe "No 

Smoking" in rail cars. Never crawl under railcars –walk around them. Avoid any cables between 

the railroad tracks. These are often used to move cars on sidings. A cable snapping taut can kill 

or maim.

S.15.4.3 Other Industries 

Other inspected commodities that can pose unique safety challenges include, but are not limited to: 

• Egg-producing facilities

• Compounding pharmacies

• Seafood

o Vessels 

• Produce farms

o Irrigation canals

• Sprouts 

o Chlorine solutions

• ITS

o Watering points

o Airports

o Cruise ships

• Imports/IMF

• Tissue/drug residues

With the above special situations, and others like them, be sure to consult any available compliance 

programs , assignments, commodity SMEs, InsideFDA.gov SharePoint sites, QMiS, as well as your IH 

liaison for safety considerations and precautions.

S.16 - Ergonomic 

Per OSHA: Musculoskeletal disorders (MSDs) affect the muscles, nerves, blood vessels, ligaments and 

tendons. You can be exposed to risk factors at work, such as lifting heavy items, bending, reaching 

overhead, pushing and pulling heavy loads, working in awkward body postures and performing the same 

or similar tasks repetitively. Exposure to these known risk factors for MSDs increases your risk of injury.

Ergonomics --- fitting a job to a person --- helps lessen muscle fatigue, discomfort, pain and reduces the 
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number and severity of work-related MSDs. Ergonomic risk factors are workplace situations that cause 

wear and tear on the body and can cause injury. These include repetition, awkward posture, forceful 

motion, stationary position, vibration and extreme temperature. Exposure to multiple factors increases 

the risk of developing MSDs.

Ergonomic injuries occur when the type of work, body positions, and/or working conditions you must 

engage in put strain on the body. Symptoms, the strain on your body or the harm that these hazards 

pose aren’t always immediately noticeable. Short-term exposure may result in “sore muscles” the next 

day or in the days following exposure, while long-term exposure can result in serious long-term illnesses. 

Poor ergonomics can lead to health issues for employees, such as cumulative trauma disorders, 

repetitive motion injuries, and musculoskeletal disorders. Often, ergonomic hazards arise due to poor or 

inadequate workplace design.

If needed, ORA Safety can provide advice on selecting tools and equipment that CSOs will use in the field 

as well as on work techniques to minimize the risk of musculoskeletal disorders. Consult with your

supervisor and/or your IH Contact(s).

S.16.1 - Force 

Tasks that require large amounts of force and/or large amounts of force relative to the affected body 

part increase the risk for ergonomic injury. Examples include forces on the lower back when lifting heavy 

objects and forces on the elbow while striking an object with a hammer. Examples of force-based 

hazards may include lifting/carrying/lowering/pushing/pulling heavy objects such as samples, sample 

supplies, or inspectional equipment

When possible, reduce the amount of force on your body when performing tasks. Effective strategies 

include using proper tools and equipment, designing and/or planning work to avoid unnecessary forces 

on the body, and using safe work practices, such as team lifting of heavy and/or awkwardly shaped 

objects. 

S.16.2 – Awkward, Same Posture/Improper Adjustments 

Working in awkward body positions and/or with equipment not properly designed for the user increases 

the risk of ergonomic injury. Examples may include hunching over a workstation that is too short or 

using equipment that hasn’t been adjusted to an individual's preference/size. Whenever possible ensure 

equipment and tools are properly adjusted to ensure user comfort and ergonomically sound positioning.

S.16.3 - Repetition 

Tasks that require multiple repetitions put cumulative stress on the affected body parts, increasing the 

risk of ergonomic injury. Examples of tasks often done repetitively or for extended periods of time 

include collecting swab samples or using a mouse and keyboard. When possible, plan work to reduce 

the number of repetitions of a task you must complete, take frequent breaks, and avoid repeatedly 

performing tasks that require large amounts of force and/or awkward positions.

S.16.4 - Cold Temperatures 

In combination with any one of the other risk factors, cold temperatures may also increase the potential 

for MSDs to develop. For example, many of the operations in food processing occur with a chilled 

product or in a cold environment.
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S.16.5. - Vibration 

Both whole body and hand-arm vibration can cause a number of health effects. Hand-arm vibration can 

damage small capillaries that supply nutrients and can make hand tools more difficult to control. Handarm vibration may cause a worker to lose feeling in the hands and arms resulting in increased force 

exertion to control hand-powered tools in much the same way gloves limit feeling in the hands. The 

effects of vibration can damage the body and greatly increase the force which must be exerted for a 

task.

S.16.5 - Special Ergonomic Situations 

Inspectional and investigational tasks with an increased likelihood of exposure to ergonomic hazards 

include sampling and processing equipment inspections that could involve lifting, improper adjustments

and repetition. Strategies for reducing the likelihood of ergonomic injury are listed below.

S.16.5.1 - Sampling 

Sampling can involve repetitious motion in awkward positions, and the transportation of sampling 

supplies to and from a firm can require large amounts of force. When sampling, try to minimize time 

spent in awkward or uncomfortable positions, and switch roles with other members of the sampling 

team periodically to reduce bodily strain. Use containers and bags that are easy to lift, preferably 

with handles on them, to transport sampling supplies. If a bag or container is heavy, request help 

from another member of the sampling team.

S.16.5.2 - Processing Equipment Inspection 

Inspecting processing equipment can require moving and or staying in awkward body positions for 

extended periods. When inspecting, use equipment such as cameras or mirrors, when possible, to 

visually inspect equipment without assuming an awkward position. If you must assume an awkward 

position, ensure you have your flashlight, camera, and/or other equipment necessary for evidence 

collection ready, to avoid remaining in the positions for longer than necessary. 

S.17 - Employee and Traveler Health and Safety 

S.17.1 - FDA Occupational Health Services (OHS) 

FDA OHS has health units established for employees to receive occupationally related medical services. 

Each health unit provides access to on-site first aid and urgent care services; onsite clinical care, referral 

and follow-up for work related injury and illness; immunizations; health risk appraisals; health 

screenings; health counseling; and health and wellness education. Services are provided by appointment 

only. To request OHS services Outside the National Capital region, send an email 

to occupationalhealthservices@fda.hhs.gov. Call 911 for medical emergencies.

S.17.2 - Immunizations 

FDA provides operating field personnel with various immunizations for protection from infection or 

injury on the job. Utilize the following CDC sites, tools, and schedules to determine your immunization 

status: 

• Adult Vaccination Home Page
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• Adult Vaccine Assessment Tool

• Adult Immunization Schedule

• Vaccine Information for Adults

S.17.2.1 - Domestic Work 

You may need vaccines based on your age, health conditions, job, lifestyle, or travel habits. Learn 

more about what other vaccines the CDC recommends for you and talk to your OHS about which 

vaccines are right for you.

S.17.2.2 - Foreign Travel 

Reference the DTO Immunizations and Other Health-Related Topics site for information on 

immunizations and/or prophylactic medications for foreign travel.

Consult with your supervisor and trip planner, well in advance of planned foreign travel, as to 

specific requirements of the countries to be visited. FDA employees are responsible for ensuring they 

have received recommended immunizations and/or prophylactic medications specific for their official 

travel destinations. Immunizations and prophylactic medications are provided at no cost to 

employees that travel internationally as part of their official duties.

S.17.3 - Physical Examinations 

There is no requirement for periodic physical examinations. Even so, it is your responsibility to adhere to 

good personal hygiene and health practices. If any firm management demands evidence of recent 

physical examination before permitting inspection, consult your supervisor. A mere request to examine 

your hands for sores, etc., is not unreasonable. However, do not accede to a physical examination.

S.17.4 - Traveler Health 

S.17.4.1 - Domestic Travel 

Refer to your division/supervision, DTO and CDC Travelers’ Health-United States for domestic travel 

health issues.

S.17.4.2 - Foreign Travel

In addition to the immunization information above for foreign travel, the Division of Travel 

Operations (DTO) has captured materials and resources that serve as a supplement to the tripspecific communications that are sent to the foreign traveler. Be sure to visit the: Pre-Travel, During 

Travel, Post-Travel, Contact Information links below to find useful information that may assist you 

through all aspects of the foreign trip process.

The Foreign Travel Resources Page is a list of helpful resources for use when conducting foreign 

travel: 

• Policy, Procedures and Guidelines

• Pre-Travel

• Health Information

• Commonly Used Terms Associated with Foreign Travel

• During Travel

• Post-Travel
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All investigators conducting ORA foreign inspections shall take required courses and trainings prior 

to departure. You should contact your program office for information on these courses.

• The online training CT401 (https://fsitraining.state.gov/home/7480) was developed for staff 

who spend 90 days or less outside of the country per year. The training remains good for six

years.

• Staff who spend 90 days or more outside the United States (including ORA foreign cadre

staff), are required to attend and complete training CT650 

(https://fsitraining.state.gov/FACT). All assigned overseas staff shall attend this intensive

course. This training remains good for six years.

S.17.4.2.1 - Pre-Travel

If the CDC has issued a Travel Notice (Level 1: Watch, Level 2: Alert, Level 3: Warning) for your 

destination, make sure to discuss the notice with your supervisor/trip coordinator and during 

your health appointment.

S.17.4.2.2 - During Travel 

This page details important information for the traveler while on official government travel.

S.17.4.2.2.1 - Medical Emergencies and/or Medical Assistance Abroad 

In case of any emergency such as illness, injury or safety concerns, travelers should seek 

medical attention immediately. After treatment, contact your supervisor, trip coordinator (if 

unavailable, the coordinator’s supervisor) or any other ORA contacts provided on the 

itinerary. Never postpone seeking medical attention if seriously ill or injured. Federal 

employees are covered by the Federal Employees’ Compensation Act (FECA) while on 

government business abroad for work-related injury or illness. Review the Medical 

Emergencies and/or Medical Assistance Abroad page for additional information.

Before travelling internationally, FDA employees should check with their private medical 

insurance providers regarding what services and coverage they will have in case they 

become ill or injured in a foreign country. FDA does not provide separate medical insurance 

or reimbursement for non-work-related medical treatment while on foreign travel. 

Commissioned Corps Officers in TDY/TAD OCONUS may seek medical care through use of 

the Tricare Overseas Program (TOP). For more information, call 1-888-777-8343 (from the

U.S.), visit TOP site for country-specific contact information or access the website at 

TRICARE Overseas (tricare-overseas.com). Also see the MyCare OverseasTM Mobile App and 

Web-Based Portal, available via laptop or personal computer, providing easy-to-access 

services, such as checking your TRICARE Health Plan, verifying TRICARE covered services, 

finding a TOP Network Provider, and offering connections to 24/7 assistance to the local 

Near Patient Team (in specified locations), the Global First Call Desk, the Beneficiary Support 

Center (BSC), as well as Technical Support. There is also a self-service ChatBot feature that 

provides immediate answers to Frequently Asked Questions, and, if needed, a link to chat 

directly with the BSC. Reference the TRICARE Overseas Handbook for additional 

information.

After obtaining any necessary emergency treatment, use the Employees’ Compensation 

Operations and Management Portal, ECOMP - U.S. Department of Labor (dol.gov), for 

completing required incident reports (OSHA-301) and worker’s comp forms (CA-1 or CA-2). 

OSHA-301 shall be completed within seven days of injury or illness. CA-1/CA-2 shall be 
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completed within 30 days. If unable to access ECOMP website, or to complete forms, 

contact your trip coordinator, or your division representative within FDA Human Resources.

S.17.4.3 - Travel Health Kit 

The CDC offers a plethora of traveler health information at CDC Travelers' Health and CDC Traveler 

Advice. At CDC Pack Smart, the CDC provides a checklist to prepare for your next trip. The website 

states that, particularly if travelling abroad, to make sure to bring items with you, since the quality 

of items bought overseas cannot be guaranteed. Not all of these items may be relevant to you and 

your travel plans. Additional travel tips include:

• Keep any needed routine prescription meds in your carry-on luggage and bring extra meds, 

if applicable, for possible travel delays. Bring copies of all prescriptions (meds, devices, 

glasses/contacts). Have letterhead letter from your health care provider for any controlled 

or injectable meds. Check with the relevant U.S. Embassy, prior to your departure, to ensure

your meds are allowed in the country. Leave a copy of prescriptions at home with your 

designated contact person. 

• Keep your health insurance card and contact information with you when abroad. Keep proof 

of yellow fever vaccination, too, if required. 

• Keep your Emergency Contact Card with you, along with a list of local 

hospitals/clinics/emergency services. You should also carry with you the name of your local 

POC, and their address and phone number at the closest U.S. Embassy or Consulate.

• Additional items for consideration in your health kit include, inhalers, epinephrine autoinjectors, medical alert bracelets, special prescriptions for trip/travel (antibiotic for 

traveler’s diarrhea, commercial suture/syringe kits for use by local physician, anti-altitude 

sickness meds, anti-malarial meds, etc.), over-the-counter meds (antacid, diarrhea meds, 

mild laxative, motion sickness, mild sedative, decongestant, pain and fever med, 

antihistamine, cough drops, saline nose spray, cough suppressant/expectorant, etc.), 

preventive items (hand sanitizer/wipes, insect repellant, permethrin, bed net, sunscreen, 

sunglasses, safety equipment, earplugs, etc.), first aid kits (first aid creams, wound 

bandages/blister care, elastic bandage wrap, eye drops, water purification tablets, oral 

rehydration salts, equipment-gloves, thermometer, scissors, swabs, tweezers, etc).

S.17.4.4 - General Precautions During Trip 

The CDC states at The CDC Survival Guide to Safe and Healthy Travel that, whatever your reason for 

traveling, you should be prepared when it comes to your health—before, during, and after travel.

Additionally, 

• Practice personal security

o Carry contact information for the nearest U.S. Embassy/Consulate. 

o Carry a photocopy of your passport and entry stamp/form.

• Note that motor vehicle crashes are the leading killer of healthy U.S. citizens in foreign 

countries.

• Follow safe eating and drinking practices.

• Prevent bug bites.

• Prepare for possible weather extremes.

• Avoid animal contact.
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• Wash hands.

• Avoid sharing body fluids. If medical or dental care needed, make sure local clinic or hospital 

employs good medical hygiene.

Note also that, in the e-clearance form provided in your foreign travel process documents, you have 

a registered country clearance with the U.S. Embassy/Consulate in that location. Your country 

clearance will be obtained for you by the Passport Office. The e-clearance form includes contact 

information, health information, security threat, immigration/customs/quarantine, climate and 

transport information. In “Contact Information” box on the form, you will see Embassy telephone 

numbers for business and after-hours. For any situation of physical or medical threat, you can 

contact the Embassy 24 hours/7 days a week.

S.17.4.5 - Additional travel resources 

S.17.4.5.1 - Travel.State.Gov

At Travel.State.Gov, the U.S. Department of State’s Bureau of Consular Affairs provides services 

that protect U.S. citizens and their interests abroad, ensure U.S. border security, facilitate the 

entry of legitimate travelers, and foster economic growth. Resources housed at this site include: 

• Travel Advisories

• U.S. Citizens in an Emergency

o If you are overseas and in need of emergency assistance contact the nearest U.S. 

embassy or consulate. 

o Call: From the U.S. and Canada: 1-888-407-4747. From overseas: +1 202-501-4444. 

S.17.4.5.2 - CDC Travelers’ Health

The CDC/Traveler's Health website is committed to updating the public with current and 

accurate information regarding COVID-19, COVID-19 related vaccines and medicines, along with 

other travel advice/recommendations, notices, and resources. You are encouraged to review 

this site frequently in advance of travel. 

S.17.5 - Employee and Traveler Safety 

S.17.5.1 - Employee Safety 

See references to personal safety in this chapter and IOM Chapter 5.

S.17.5.2 - Traveler Safety Tips 

• Conduct research into your destination(s).

• Keep travel plans private but check in with a trusted network often.

• Write down emergency information.

• Keep photocopies/scans/photos of important documents.

• Lock up your valuables

• Don’t draw attention to yourself.

• Don’t share too much information with strangers. 

• Stay “tethered” to your bags/equipment.

• Practice situational awareness; be aware of your surroundings.

• Avoid unsafe, “sketchy” vicinities.

• Don’t advertise valuables.
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• Use ATMs wisely.

• Trust your instincts.

• Do not bring anything with you that is irreplaceable if stolen.

• Drink alcohol responsibly.

• Choose safe foods and drinks when traveling per the CDC and consider the following 

suggestions:

o Eat at popular places with long lines.

o Try to watch how your food is prepared.

o Pack translation cards to document your allergies.

o Fully cooked, hot food is always the safest.

o Only eat peelable fruit to avoid bacteria. 

o Avoid fresh salads and other raw foods.

o Do not drink the tap water or use ice in developing countries.

o Drinks from unopened, factory-sealed bottles or cans are best.

S.17.5.3 - Motor Vehicle Safety 

Per the CDC/NIOSH Transportation Safety | Motor Vehicle Safety | CDC Injury Center, driving or 

riding in a vehicle as part of your job can add to your risk of injury. Motor vehicle crashes are a 

public health concern both in the United States and abroad. In the United States, motor vehicle 

crashes are a leading cause of death, and kill over 100 people every day. However, motor vehicle 

crash injuries and deaths are preventable. There are proven strategies that can help prevent these 

injuries and deaths. Whether you are a driver, passenger, cyclist, or pedestrian, you can take these 

steps to stay safe on the road:

• Make sure your vehicle works properly.

• Always use seat belts, obey speed limits, and keep a safe following distance.

• Stay focused on the driving task by avoiding distractions.

o Don’t talk on hand-held cell phones or use other handheld devices. Avoid hands-free 

phones too – any phone conversation can be a distraction. 

o Don’t text.

o Don’t adjust controls.

o Don’t eat or drink.

o Don’t drink alcohol and drive.

o Don’t be distracted by passengers.

o Keep your eyes on the road, and your hands on the steering wheel.

• Slow down when you get near intersections.

• Drive cautiously, especially when you see objects in or next to the road.

• Make sure you are well rested before you start driving.

Before operating a vehicle, check the following:

1. Tires, check for tread wear, inflation, etc.

2. Mirrors, for proper adjustment

3. Brakes for operability as much as possible

4. Windshield for visibility

5. Lights: headlight, turn signals and brake

6. Gasoline and oil gauges to determine levels
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7. Spare, jack, lug wrench, first aid kit, flares, etc.

Note: Fire extinguishers are no longer required in vehicles.

When transporting materials of trade, or items that when shipped commercially would be regulated 

as hazardous materials/dangerous goods, it is strongly recommended to adhere to US DOT 

regulations, even though it may not in all instances be required. Ensure that all volatile solvents--

either in the sample collection kit or contained in a sampled material--are properly packaged and 

sealed to prevent spills or leakage. Be especially aware of the hazards associated with transporting 

dry ice as a concentration of carbon dioxide gas can occur, potentially causing a dangerous overpressurization, and/or a loss of oxygen, which can in turn, lead to hazards for users/handlers, such 

as feelings of drowsiness, or even an asphyxiation. Storing dry ice adequately, in a proper container, 

and transporting it in an adequately ventilated vehicle (windows cracked/down) reduces such risks. 

S.17.5.3.1 - Global Road Safety 

Per the CDC, whether you’re on the road at home or abroad, you should know the risks and take 

steps to protect your health and safety both domestically and globally. When travelling by 

vehicle globally:

• Always use a seat belt on every trip, no matter how short--and no matter if you are 

seated in the front or the back of a vehicle.

• Always wear a helmet when driving or riding on motorcycles, motorbikes, or bicycles. 

• Do not drive while impaired by alcohol or drugs, or with a driver who is impaired.

• Obey speed limits.

• Drive without distractions. For example, don’t use a cell phone, or text, while driving.

• Be alert when crossing streets, especially in countries where motorists drive on the left 

side of the road.

• Ride only in marked/official taxis or ride share vehicles. Try to ride in taxis or ride share 

vehicles that have seat belts available in all seating positions.

• Avoid riding in overcrowded, overweight, or top-heavy buses or minivans.

• Check the Association for Safe International Road Travel (ASIRT) website for information 

about driving hazards and road safety risks, by country.

• For more information about road safety, overall safety, and security in every country of 

the world, visit the country information page on the U.S. Department of State website.

• Reference the CDC Health Information for International Travel (Yellow Book 2020).

Chapter 8 – Travel by Air, Land & Sea – Road & Traffic Safety. 2020 Edition. Available 

at: https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-by-air-land-sea/road-andtraffic-safety. 
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Exhibits 

Exhibit S-1 - ORA “Quick Steps” Employee’s Guide to Incident Reporting 

In case of occupational injury or illness, employees have a right to obtain first aid or medical treatment. 

All work-related incidents, injuries, illnesses, near misses, or property damages must be reported. The 

following describes the steps employees should take to, first, acquire necessary first aid, and, secondly,

the steps they should follow to report occupational injuries and illnesses: 

1. If situation is severe, call 911 for immediate medical assistance. If the situation is not severe, 

report the incident to your supervisor and management. You may choose to visit an 

Occupational Health Clinic or a private physician. 

2. Obtain the following forms from your supervisor, complete them, and provide them to the 

physician, at the clinic you are visiting for medical treatment: 

a. A completed and signed Form CA-16, “Authorization for Examination and/or 

Treatment.” In instances in which emergency treatment is/was received, the CA-16 

should be issued within 48 hours after treatment. 

b. A completed copy of Form CA-17, “Duty Status Report,” so that the physician can

document any work restrictions, if assigned. 

c. If you decide to be treated by a private physician, please take a copy of the American 

Medical Association Standard Billing Form (AMA) OWCP-1500 , along with the Form CA16. 

All work-related incidents, injuries, illnesses, near misses, or property damages must be reported using 

the following steps: 

1. File the incident report as soon as possible in the employee Incident Portal, pOSH+ (within seven 

days from the date of incident). An employee step-by-step pOSH+ Incident Reporting Guide is 

available for help to complete the report. Additional employee resources can be found on the 

ORA Safety webpage. Complete all required fields denoted with a red asterisk*.

a. Save your report as you complete each step. 

b. Submit your report once all information has been entered by clicking the submit field on 

the upper right-hand corner. 

c. Your supervisor will review and forward your report to ORA Safety, who will then 

review, investigate, and submit a completed report to pOSH+. 

2. If you want to file a “Worker’s Compensation Claim,” you must register in ECOMP, file an OSHA 

301 Injury and Illness Incident Report, and then, file either Form CA-1 “Federal Employee’s 

Notice of Traumatic Injury and Claim of Continuation of Pay/Compensation,” or Form CA-2 

“Notice of Occupational Disease and Claim for Compensation.” 

a. The CA-1 must be filed along with medical documentation associated with the injury 

within 30 days from the date of injury, to be eligible for continuation of pay (COP). COP 

and medical evidence supporting disability must be provided within 10 calendar days 

after submitting the claim for COP. 

b. See procedures for accident reporting, medical surveillance programs, and worker 

compensation OWCP Employee’s Guide at: Instructions for Injured Employees (fda.gov)
CHAPTER S INVESTIGATIONS OPERATIONS MANUAL 2023

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Your supervisor will review the report in ECOMP. An ORA Safety IH will review, 

investigate, complete and file the final OSHA 301 report in ECOMP. 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER S 

S - 81

Exhibit S-2 - ORA “Quick Steps” Supervisor’s Guide to Incident Reporting 

In case of occupational injury or illness, employees have a right to obtain first aid or medical treatment. 

All work-related incidents, injuries, illnesses, near misses, or property damages must be reported. 

Supervisors should consult the steps below for assisting an employee during an occupational injury and 

illness. 

If an employee has sustained a work-related injury, please follow the steps outlined below: 

1. Check on the employee to ascertain general status, condition, and/or need for assistance. 

2. If situation is severe (for instance, employee is nonresponsive), call 911 for immediate medical 

assistance. If the situation is not severe, refer the employee to the Occupational Health Clinic, if 

available, and/or to a private physician, if needed. The employee may choose where they want 

to be treated. 

3. Provide the following forms to an injured employee who is requesting to seek medical 

treatment:

a. Completed and signed Form CA-16, “Authorization for Examination and/or Treatment”, 

to the employee within four hours of the request for medical treatment and prior to 

seeking medical attention. You can obtain a copy of the CA-16 from your designated 

Industrial Hygienist. Refer to the Office of Workers’ Compensation Programs 

Supervisors’ Guide for additional guidance and exceptions on providing the CA-16.

i. Form CA-16 should not be issued if more than a week has passed since the 

injury. 

ii. If you doubt whether the employee’s condition is related to their employment, 

you should indicate this on Form CA-16 (item 6.B.2). 

iii. Form CA-16 should not be issued retroactively for treatment already received, 

except in the case of emergency treatment. In instances in which emergency 

treatment is/was received, the CA-16 should be issued within 48 hours after 

treatment. 

b. Completed Form CA-17, “Duty Status Report,” with the employee’s position description 

so that the physician can document any work restrictions, if assigned. 

All work-related incidents, injuries, illnesses, near misses, or property damages must be reported using 

the following step(s): 

1. Refer your employee to the Incident Portal, pOSH+ to file a report. An employee Getting Started 

in pOSH+ Guide is available to help complete the report. Visit the ORA Safety SharePoint for 

additional resources.

a. Once the employee completes and submits the pOSH+ incident report, you will receive 

an email that the investigation is ready for your review. 

b. Review, sign, and submit the pOSH+ Incident Investigation as soon as possible. A 

supervisor’s guide, How to Review an Incident Report Submitted by an Employee, is 

available. 

2. If your employee wants to file a “Worker’s Compensation Claim,” refer them to ECOMP to 

register, file an OSHA 301 Injury and Illness Incident Report, and, either a Form CA-1, “Federal 

Employee’s Notice of Traumatic Injury and Claim of Continuation of Pay/Compensation,” or a 

Form CA-2, “Notice of Occupational Disease and Claim for Compensation.”
CHAPTER S INVESTIGATIONS OPERATIONS MANUAL 2023

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a. Inform your employee that the OSHA 301 Injury and Illness Incident Report must be 

filed within 7 days from the date of the injury, and that the Form CA-1 must be filed 

within 30 days from the date of injury to be eligible for continuation of pay (COP). 

b. Once the employee completes and submits documents in ECOMP, you will receive an 

email that the incident paperwork is ready for your review. 

c. Review the employee’s OSHA 301 and CA-1/CA-2, if applicable. Complete the 

supervisory portion in ECOMP as soon as possible, but no later than 7 days. Supervisors 

will receive reminder emails from ECOMP if the portion that they are responsible for is 

not completed within 2 days. 

3. ORA Safety will review, investigate, complete, and file the final pOSH+ and OSHA 301 reports in 

ECOMP. 
INVESTIGATIONS OPERATIONS MANUAL 2023 CHAPTER S 

S - 83

INDEX 

A

Accidents ...........................................................63, 64

Allergens....................................................3, 4, 41, 56

Allergy......................................................9, 41, 56, 75

Ammonia ............................. 23, 28, 32, 33, 34, 36, 54

ANSI .......................................................20, 21, 26, 34

ASIRT........................................................................77

ASTM........................................................................21

C

CDC ................................ 25, 57, 71, 72, 74, 75, 76, 77

Clothing........ 19, 20, 21, 24, 25, 36, 38, 40, 56, 58, 66

Cold..........................................................................32

Combustible...........................................28, 29, 48, 51

Conduct ...........................................17, 32, 46, 47, 67

Consulate...........................................................73, 74

COOP........................................................................17

CORE ........................................................................17

D

Dosimeter..........................................................65, 66

DOT............................................ 31, 36, 37, 51, 66, 76

Drug ...................................................................17, 69

Dry Ice......................................................................57

DTO Domestic Travel .........................................71, 72

Dust............................ 6, 19, 23, 27, 28, 29, 42, 47, 56

E

ECOMP...............................................................12, 73

Embassy.............................................................73, 74

Emergency .....1, 16, 17, 18, 27, 32, 34, 65, 66, 67, 72, 

73, 74, 75

Energy........................ 4, 29, 30, 38, 39, 51, 58, 62, 63

eNSpect..........................................................9, 10, 11

EPA.........................................................18, 22, 34, 35

ERC...........................................................................17

Ethylene Oxide.......................................23, 28, 32, 38

Explosive..........................................22, 29, 50, 51, 52

Exposure ..6, 12, 13, 16, 18, 19, 22, 23, 24, 32, 35, 36, 

37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 

52, 54, 55, 57, 58, 59, 64, 65, 69

F

Federal Protective Service ......................................... 9 

Flammable .......................................28, 48, 50, 51, 54

flashlights.....................................................29, 59, 68

FMS................................................................9, 10, 11

Foreign Travel ....................................5, 71, 72, 73, 74

Fumes ......................................................6, 23, 31, 47

Fumigation......2, 23, 31, 32, 33, 34, 35, 36, 37, 56, 68

G

Gases ..........4, 6, 23, 28, 31, 35, 49, 50, 51, 52, 54, 67

Glasses.........................................................20, 26, 73

Gloves................ 19, 21, 24, 25, 40, 43, 45, 56, 57, 73

Grab and Go.......................................................44, 47

Grain .......................................... 23, 28, 31, 39, 67, 68

H

Hand Hygiene ..........................................................25

Hardhats..................................................................21

Hazard 2, 3, 4, 6, 7, 8, 9, 11, 13, 14, 15, 16, 17, 18, 19, 

20, 21, 23, 24, 25, 27, 28, 29, 30, 31, 32, 33, 34, 

35, 36, 37, 38, 39, 40, 42, 43, 44, 45, 46, 47, 48, 

49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 

62, 63, 64, 65, 66, 67, 68, 69, 70, 76, 77

I

IAP ............................................................................16

IARC .........................................................................49

IATA .......................................................36, 37, 57, 66

ICS ......................................................................16, 17

IH 12, 14, 17, 19, 20, 21, 22, 24, 26, 30, 31, 40, 43, 

46, 47, 56, 59, 60, 66

IMG ..........................................................................16

IMT .....................................................................16, 17

Insurance ................................................................. 73

Intrinsic Safety .........................................................29

Ionizing ..................................................58, 64, 65, 66

J

Jewelry...............................................................20, 66

L

Labeling..................................................13, 46, 53, 55

Lighting ..................................................29, 30, 58, 59

Lithium................................................................. 2, 30

M

Medical ..7, 8, 9, 14, 29, 35, 37, 40, 59, 64, 66, 67, 70, 

72, 73, 74

MOU ........................................................................18
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S - 84

N

NIMS ........................................................................17

NIOSH ........................................ 18, 22, 24, 39, 57, 75

Noise..................................................................22, 58

Non-ionizing.............................................................64

NTP ..........................................................................49

O

OCI .........................................................................8, 9

OEL...........................................................................24

OHS .............................................. 5, 16, 19, 44, 70, 71

OLS...............................................................12, 13, 44

ORA Safety Office .................. 2, 12, 13, 16, 19, 26, 64

ORADSS...................................................................... 9 

Organization ......................................................16, 52

OSH..............................................................11, 18, 58

OSH Act..................................................11, 17, 18, 58

OSHA....1, 6, 13, 14, 15, 17, 18, 20, 22, 23, 24, 27, 28, 

29, 30, 37, 38, 39, 44, 48, 49, 50, 52, 55, 60, 61, 

62, 65, 67, 73

Oxygen-deficient......................................................30

Ozone.................................................2, 23, 32, 38, 54

P

Penicillin.........................................................9, 10, 57

Personal Protective Equipment.. 1, 2, 8, 9, 12, 13, 14, 

19, 20, 23, 24, 25, 26, 27, 40, 41, 42, 43, 44, 45, 

46, 56, 57, 58, 64, 68

Personal Safety .......1, 6, 7, 8, 9, 10, 11, 46, 56, 57, 75

Personal Safety Alert.........................1, 8, 9, 10, 11

Personal Safety Plan.............................................. 8 

Personal Safety Risk................................................... 8 

pOSH+................................................................12, 13

Poultry ...........................................................3, 23, 43

Primate ................................................................3, 44

Property..................................... 12, 13, 46, 52, 54, 67

PSM..........................................................................27

R

RAC ..........................................................................35

Radiation...........4, 6, 16, 20, 26, 27, 49, 58, 64, 65, 66

Reporting .................................................1, 12, 13, 16

Reproductive ...............................................37, 39, 48

Respiratory ..2, 3, 9, 14, 16, 19, 22, 23, 24, 25, 26, 33, 

34, 35, 37, 38, 40, 42, 43, 45, 47, 48, 49, 53, 54, 

55, 56, 57, 58, 66

Retorts.....................................................................31

Rodent ................................................................. 3, 43

S

Sampling 4, 5, 7, 31, 35, 36, 37, 43, 45, 52, 56, 57, 64, 

66, 68, 69, 70, 76

SDS...................................................32, 36, 46, 52, 53

Shoes ...............................................20, 21, 25, 26, 57

SVEP.....................................................................1, 18

T

Tampering......................................................8, 17, 19

Thermometers.........................................................73

Tobacco .................................................23, 29, 42, 47

Training..13, 16, 17, 19, 24, 26, 53, 57, 58, 59, 60, 63, 

64, 65, 66, 67, 72

Travel ..................................... 5, 71, 72, 73, 74, 75, 77

TRICARE ...................................................................73

U

UL29

V

Vaccination ......................................43, 44, 45, 71, 73

Vapor ................................... 23, 28, 29, 42, 47, 49, 52

Vehicle ....................... 5, 23, 63, 64, 67, 68, 74, 75, 76