Contents

SUBCHAPTER 140 - SAFETY

Safety is a responsibility of FDA employees, their supervisors, and the Agency's management. These responsibilities include (1) the reporting of any hazards or suspected hazards, (2) taking the necessary safeguards to minimize the opportunity for safety problems. The Agency cannot permit 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. Refer to IOM 510.01 – Personal Safety for additional inspectional safety concerns.

Be alert for problems associated with defective or misused equipment or supplies and their possible impact on patients and/or users. Contact your supervisor and/or the headquarters contacts listed in the applicable compliance program as necessary for assessment. The home district of the manufacturer should be notified of product misuse, so it may be brought to the manufacturer's attention for consideration of precautionary labeling or redesign of the product. Fully document these problems, to include the hazard and/or defect observed and whether 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.

When conducting an inspection or collecting a sample in a facility which requires donning personal protective equipment, guidance should be provided by the firm's management as follows:

1. Information about the specific hazards that may be encountered
2. The potential concentrations of these hazards
3. The personnel protective equipment determined to protect against these hazards

The firm's management should be able to provide you with documentation showing how these hazards were determined, what the expected exposures are and how they relate to the Occupational Safety and Health Administration's (OSHA) Permissible Exposure Limit (PEL). It should also offer information about the personal protective equipment that will protect you against a hazardous exposure. If you have any doubts about the hazards or the equipment recommended or provided to protect against them, do not enter these areas. Your Regional Industrial Hygienist or the Office of Regulatory Affairs (ORA) Safety and Occupational Health Manager may be able to help you evaluate the information provided to you, or furnish information regarding the hazard and the recommended personal protective equipment.

If you do not have the specific personal protective equipment recommended by the firm's management, have your District furnish what you need. In some cases, the firm may be willing to provide the necessary personal protective equipment, however if respiratory protection is required, you should not wear any respiratory protection unless your District has a written Respiratory Protection Program and you have been certified by your District's Respiratory Protection Program Administrator as having currently met the requirements of this program. See IOM 141. It is ultimately your responsibility to ensure that you do not expose yourself to any hazard.

Disaster conditions present inherently dangerous situations. See IOM 940.

Operations in the radiological area also pose special dangers. See IOM 144.02. Obtain advice on protective measures from regional radiological health personnel.

141 - PROTECTIVE EQUIPMENT

141.01 - Eye Protection

Wear safety glasses during all inspectional activities in which there is a potential for physical or chemical injury to the eye. These glasses should, at a minimum, meet the American National Standard Z87.1-1989 standard for impact resistance. Guidance should be provided by the management of the facility being inspected as to additional eye protection required. Unvented goggles should be worn whenever there is the potential for a chemical splash or irritating mists. Additional eye protection may be required in facilities that use exposed high intensity UV lights for bacteriostatic purposes, tanning booth establishment inspections (EIs), etc. Follow the manufacturer's recommendation regarding eye protection for any instrumentation generating light in the UV or higher energy wavelength range.

141.02 - Hearing Protection

You should wear hearing protection in noisy areas. The OSHA PEL for employees exposed to noise ranges from 90 decibels for an 8-hour time-weighted average to 115 decibels for 15 or fewer minutes per day. However, risk factors for hearing loss include personal susceptibility, noise intensity, noise frequency, distance from the noise source, etc. The noise reduction rating is provided by the manufacturer of various earplugs and muffs, but also depends on the appropriate fit. The efficiency of muff type protectors is reduced when they are worn over the frames for eye-protective devices.

141.03 - Protective Clothing

1. Wear safety shoes on inspections, as required.
2. Wear hard hats in hard hat designated areas
3. Use appropriate gloves to avoid slivers and/or splinters when handling rough wooden cases or similar items. Use protective gloves when handling hot items or working around steam pipes, and when handling frozen products or working in freezers. Use protective gloves when handling lead pigs containing radioactive materials to avoid hand contamination. If you are handling solvents, wear gloves that are impermeable to the solvent. Your regional industrial hygienist or the ORA Safety and Occupational Health Manager can provide guidance in the type of gloves to use for a particular solvent.
4. Plan ahead for the clothing that may be required for a particular location or situation. Such clothing includes coveralls, lab coats, freezer coats, rubber or vinyl aprons, and disposable paper-like coveralls.

141.04 - Respiratory Protection

If it is possible to perform an inspection without entering areas in which respiratory protection is mandated or recommended, do not enter these areas. If you determine it is necessary to enter an area in which you must wear a respirator, you must have documented evidence showing the requirements of the District Respiratory Protection Program have been met prior to wearing your respirator. Your District shall have a written Respiratory Protection Program, as delineated in the following paragraph.

In any workplace where respirators are necessary to protect the health of the employee, or whenever respirators are required by the employer, OSHA requires the employer to establish and implement a written respiratory protection program with worksite specific procedures according to the requirements in 29 CFR 1910.134. The program must include the following provisions:

1. Procedures for selecting respirators for use in the workplace, and annual fit testing of each employee wearing the selected respirator(s);
2. Medical evaluation of employees required to use a respirator prior to the employee's use of a respirator, and repeated as specified in the Respiratory Protection Program (a medical evaluation can be obtained by contacting your local Industrial Hygienist or Ann Gallman, SERL. (404) 253-2214;
3. Procedures for using respirators in routine and reasonably foreseeable emergency situations;
4. Procedures for maintaining respirators;
5. Training of employees in the hazards to which they are potentially exposed during routine and emergency situations, and in the proper use of respirators including limitations of their use and fit checking procedures each time the respirator is donned;
6. Procedures for regularly evaluating the effectiveness of the program. OSHA requires each employer perform an evaluation of any workplace which may contain respiratory hazards. If these respiratory hazards cannot be removed through engineering controls, the employer must provide respirator protection. Do not enter any area you suspect may contain an unevaluated respiratory hazard. Your training should include a determination of the minimum respiratory protection for each type of inspection you may perform. Your regional Industrial Hygienist or the ORA Safety and Occupational Health Manager may be consulted for guidance in the type of respirator, type of cartridge or filter, and the useful life of the cartridge or filter.

The following list includes situations, which have been identified as having the potential for respiratory hazards:

1. Feed or drug plants where there is a possible inhalation hazard due to airborne
   particulates.
2. Fumigation or storage facilities where treated grain or produce is encountered,
   including trucks, vessels, railroad cars, fumigation chambers.
   
   • Do not enter any structure or conveyance or sample any product that is being treated with the fumigants Methyl Bromide or Phosphine.
   • Areas and/or products being treated with fumigants are required by Environmental Protection Agency (EPA) to be placarded, and the placards not removed until the treatment is complete (usually 12 hours to 4 or more days) and the areas and/or products are clear of fumigant gases (phosphine <0.3 ppm and methyl bromide <1 ppm).
   • Self-contained breathing apparatus (SCBA) is generally the only respiratory protection gear approved for use in areas being fumigated. It is necessary to follow many other precautions when working around fumigants. See Note on Methyl Bromide and Phosphine at the end of this section for additional information.
3. Facilities using ozone, or where ozone is produced as a by-product of the manufacturing operation.
4. Facilities where sterilizers utilize ethylene oxide gas (EO) - See IOM 144.02 Factory Inspection
5. Grain elevators or other grain storage facilities that potentially contain aflatoxin in the dust.
6. Spice grinders and repackers that potentially produce airborne respiratory irritants such as pepper.
7. Any rodent-infested area. - See IOM 145.04 Hantavirus Associated Diseases

Note - Methyl Bromide and Phosphine

If a sampling area is suspected of having been fumigated with methyl bromide or phosphine, and has not been cleared according to the EPA requirements, contact your local industrial hygienist 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. If entry is required using personal protective equipment, you local industrial hygienist can provide guidance to ensure you are using the appropriate respirator and cartridge, and any other protective equipment necessary based upon the fumigant concentration. See IOM 143.04, Asphyxiation Hazards, and IOM 144.02, Factory Inspections, for additional cautions related to fumigants.

142 - AUTOMOBILE SAFETY

Automobile Condition - See IOM 165.

Prior to driving, check the following: (1) Tires, check for tread wear, etc.; (2) Mirrors, for proper adjustment; (3) Brakes; (4) Windshield; (5) Lights, headlight, turn signals and brake; (6) Gasoline & oil gauges; (7) Spare, jack, lug wrench, first aid kit, flares, etc.; (8) Fire extinguishers are no longer required in vehicles; (9) Seat belts must be used.

Ensure all volatile solvents, either in the sample collection kit or contained in a sampled material, are sealed to prevent contamination of the air in a closed vehicle. Be especially aware of the hazard of transporting dry ice in a closed vehicle. The concentration of carbon dioxide gas can cause drowsiness, or even an asphyxiation hazard, if the dry ice is carried in an unventilated vehicle. See IOM 143.04 Asphyxiation Hazards.

143 - SAMPLING

When you are collecting samples, always be alert for possible dangerous conditions (e.g., poisonous materials or fumes, flammable or caustic chemicals, high places, etc.)

143.01 - Sample Fumigation and Preservation

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. Contact your servicing laboratory for the appropriate precautions necessary with these chemicals.
3. Material Safety Data Sheets (MSDS) for each of these chemicals must be available at each duty site (e.g., District office, resident posts), and can be obtained from your servicing laboratory. These sheets list the hazards involved with these chemicals and precautions to take for use. You must read and follow the instructions in the MSDS prior to using the chemical. If a measured amount of chemical fumigant or preservative is present at the time of shipping, enclose a copy of its MSDS with the shipped sample. Again, if you have any questions, contact your servicing laboratory.
4. Avoid excessive heat and open flame.
5. Use glass vials or jars with lined lids whenever possible. Depending on the type of fumigant used, some polypropylene containers can also be used.

143.02 - Electrical Hazards

Many samples are collected in poorly lighted areas, or in older poorly wired buildings. Be alert for low hanging wires, 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 Inspectors Technical Guide # 22 regarding Ground Fault Circuit Interrupters, and use one if feasible. Do not use flash units in dusty areas because of the possibility of explosion hazard. See IOM 523 for additional information.

143.03 - Physical Hazards

Be alert for dangerous conditions on all sampling operations. If it is necessary to use a flame to sterilize sampling equipment, use extreme care.

All flammable liquids in your sampling kits must be in metal safety cans. See IOM 426.01

Care must be taken when handling sharp objects, e.g.; knives, syringes with needles, glass, etc. If it is necessary to sample such objects, take care in packing the sample to avoid injuring anyone who handles the sample later. Place them in a rigid container, e.g. glass jar, plastic box, etc. In addition, state in the Remarks or Flag Section of the Collection Report (C/R) (FDA-464) that a syringe & needle were collected as part of your sample.

1. Railcars
   1. When sampling, make sure doors are propped open to avoid accidental closing if the car is bumped while you are in it.
   2. Display a warning flag or similar device to alert others you are in the car. If possible, have a railroad yardman present.
   3. When entering the car make sure the ladder is secure.
   4. On hot days, or after a car has been fumigated, it should be aired out prior to entering, preferably by opening both doors.
   5. Observe "No Smoking" in rail cars.
   6. Don't crawl under railcars - go around them.
   7. Avoid any cables between the railroad tracks. These are often used to move cars on sidings. A cable snapping taut can kill or maim.
2. Grain Elevators
   1. Prior to use, make sure man lifts are operating properly.
   2. Make sure cross-rungs on ladders are safe.
   3. When stepping off ladders or man lifts, be sure the floor is actually a floor and not a bin covered with canvas, cardboard, or other temporary non-supportive cover.
   4. Make sure walkways between bins are sturdy.
   5. Use caution when sampling from high bins or tanks. Wet or icy conditions may prevail, so check these conditions.
   6. When brass grain bombs are used to collect bin samples, do not drop the bomb to the surface of the grain. This could cause sparks if it hits the bottom or side of a bin. 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.
3. Clothing
   1. Do not wear loose fitting clothes when collecting samples or conducting inspections, the clothes could catch on equipment or conveyor belts and lead to injuries.
   2. Do not carry notebooks, credentials, etc., in the outer pockets of your inspectional uniform because they could fall into the equipment.
   3. Steel mesh gloves should be worn when cutting portions from frozen products such as fish, etc.
4. Trucks - Make sure any truck you enter during sampling and/or inspection will remain stationary while you are in it.

143.04 - Asphyxiation Hazards

1. Prior to entering closed areas, ascertain if they have been fumigated and, if so, air them out prior to entering.
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 decomposing, 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 (See IOM 144.02, 452.05, and 943 for additional dry ice cautions).
5. When sampling from the top of a grain elevator, do not jump down on 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, e.g., where oxygen has been replaced by carbon dioxide to prolong fruit storage, added sulfur dioxide for preservation purposes, etc. These areas must either be aerated prior to entering, or Oxygen Breathing Apparatus (OBA) must be used.

143.05 - Radioactive Product Sampling

The sampling and viewing of radiopharmaceuticals may be accomplished working through a lead shield or viewing through lead glass and using protective clothing latex gloves and tongs to prevent exposure to "unnecessary" radiation.

143.06 - Chemical Hazards

You may be assigned to collect samples of FDA regulated products involved in a wreck where chemicals pose a threat, or in areas of chemical spills or hazardous waste sites. In such instances, unprotected personnel are not permitted into hazardous zones. You will be permitted into those areas deemed safe, however, consult with the on-site DHHS Coordinator, usually an employee of the Agency For Toxic Substances and Disease Registry (ATSDR), to ascertain if any safety precautions are necessary on your part. Follow instructions provided. See IOM 322 for further information and for the address and phone numbers of the ATSDR contacts.

143.07 - Carbadox Sampling

Concentrated Carbadox (above 95%) has a severe dust explosiveness rating, is a flammable solid, and is also carcinogenic. The only approved source of Carbadox in the US is "Mecadox 10", a medicated pre-mix at a 2.2% concentration.

High concentrations of Carbadox (up to 99%) have been found during investigations of illegal bulk drugs. Some have been falsely labeled as Mecadox. Carbadox, in its pure form, is a minute yellow crystal. It is considered dangerous. Do not collect physical samples of any bulk substance identified or represented as Carbadox or Mecadox. The Center for Veterinary Medicine (CVM) will take action on documentary samples.

If there is no labeling and/or a dealer refuses to identify any yellow powder, inform the dealer of the hazards of Carbadox. Contact your supervisor before collecting any samples of suspected Carbadox. If instructed to collect a sample, use extreme caution and proceed as follows: (1) Wear disposable gloves: (2) Use a respirator or other effective means to avoid breathing the dust. Paper masks are not adequate; (3) Use goggles; (4) Do not sample in drafty places; (5) Use only plastic bottles with plastic caps; (6) Collect only 1-2 oz. per sub; (7) Cover material collected with at least an equal amount of distilled or deionized water and gently mix. It is preferable to use too much water than not enough; (8) Note on collection report (CR) the approximate amount of water added to the bottle of suspect product; (9) Protect subs from excessive heat and do not store in the trunk of car in the sun; (10) Store in insulated cartons with ice, if necessary; (11) Flag the CR as to possible presence of Carbadox; (12) Notify the receiving laboratory of sample collection.