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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 1.5 - SAFETY

1.5 - SAFETY
1.5.1 - PROTECTIVE EQUIPMENT
      1.5.1.1 - Eye Protection
      1.5.1.2 - Hearing Protection
      1.5.1.3 - Protective Clothing
      1.5.1.4 - Respiratory Protection
         1.5.1.4.1 - PROGRAM PROVISIONS
         1.5.1.4.2 - FIRMS WITH POTENTIAL RESPIRATORY HAZARDS
      1.5.1.5 - Health and Hygiene
1.5.2 - AUTOMOBILE SAFETY
1.5.3 - SAMPLING
      1.5.3.1 - Sample Fumigation and Preservation
      1.5.3.2 - Electrical Hazards
      1.5.3.3 - Physical Hazards
         1.5.3.3.1 - RAIL SAFETY
         1.5.3.3.2 - GRAIN ELEVATORS
         1.5.3.3.3 - CLOTHING
         1.5.3.3.4 - TRUCKS
      1.5.3.4 - Asphyxiation Hazards
      1.5.3.5 - Radioactive Product Sampling
      1.5.3.6 - Chemical Hazards
      1.5.3.7 - Carbadox Sampling
1.5.4 - INSPECTIONS
      1.5.4.1 - Man Lifts and Ladders
      1.5.4.2 - Factory Inspection
         1.5.4.2.1 - RETORTS
         1.5.4.2.2 - THERMAL
         1.5.4.2.3 - CHEMICAL
         1.5.4.2.4 - IONIZING RADIATION
1.5.5 - MICROBIOLOGICAL HAZARDS
      1.5.5.1 - Animal Origin Products
      1.5.5.2 - Viral and Other Biological Products
         1.5.5.2.1 - PROTECTIVE AND PREVENTIVE MEASURES
         1.5.5.2.2 - VIRAL HEPATITIS AND HUMAN IMMUNODEFICIENCY VIRUS
         1.5.5.2.3 - PRECAUTIONS FOR NON-CLINICAL LABORATORY INSPECTIONS
      1.5.5.3 - Bacteriological Problems
      1.5.5.4 - Hantavirus Associated Diseases
1.5.6 - WIRELESS DEVICES
1.5.7 - REPORTING


 1.5 - 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 5.2.1.2 - 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) National Safety Officer 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 1.5.1. It is ultimately your responsibility to ensure that you do not expose yourself to any hazard.

Disaster conditions present inherently dangerous situations. See IOM 8.5.

Operations in the radiological area also pose special dangers. See IOM 1.5.4.2.4. Obtain advice on protective measures from regional radiological health personnel.


 1.5.1 - PROTECTIVE EQUIPMENT


 1.5.1.1 - 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 Standards Institute (ANSI) standard for impact resistance. Guidance should be provided by the management of the facility being inspected as to additional eye protection required. Indirectly vented or 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.


 1.5.1.2 - 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.


 1.5.1.3 - 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 National Safety Officer 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.


 1.5.1.4 - 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 IOM 1.5.1.4.1.


 1.5.1.4.1 - PROGRAM PROVISIONS

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.
  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.


 1.5.1.4.2 - FIRMS WITH POTENTIAL RESPIRATORY HAZARDS

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.
    1. Do not enter any structure or conveyance or sample any product that is being treated with the fumigants Methyl Bromide, Phosphine or Sulfuryl Floride. If a sampling area is suspected of having been fumigated with methyl bromide, phosphine, or Sulfuryl Floride 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, your 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 1.5.3.4, Asphyxiation Hazards, and IOM 1.5.4 Inspections, for additional cautions related to fumigants.
    2. 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).
    3. 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 1.5.4.2 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 1.5.5.4 Hantavirus Associated Diseases.
  8. Poultry Houses – exposure to particulates, chemicals and possible infectious agents.


 1.5.1.5 - Health and Hygiene

Inoculations - FDA provides operating field personnel with various inoculations for protection from infection or injury on the job.

The following schedules of shots are recommended:

  1. Domestic Work:
    1. Tetanus: Permanent immunity through the Tetanus Toxoid series followed by a booster dose every ten years;
    2. Typhoid: No longer required even if working in a contaminated environment. Booster dose may be given every three years if desired and requested by employee;
    3. Smallpox: No longer required in the U.S.;
    4. Other: As required by your specific job.
    5. Hepatitis B Vaccine: a synthetic vaccine has been developed and is available to those employees that may be exposed to the virus during the normal course of official duties. Contact your AO to arrange for this vaccination. Keep in mind a vaccination is not to be considered a substitute for good laboratory/field safety practices. This vaccine is specific for Hepatitis B virus (HBV) only, and not for other blood pathogens.
  2. Foreign Travel - Check with your supervisor well in advance of planned foreign travel as to specific requirements of the countries to be visited.
    1. Typhoid: recommended for travel to areas where typhoid fever is endemic.
    2. Cholera: a primary vaccination or a booster within six months is required for traveling to India and Korea. May also be required occasionally for other nations.
    3. Other: as required for specific country.

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.


 1.5.2 - AUTOMOBILE SAFETY

Automobile Condition - See IOM 1.6.2.

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 and 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 1.5.3.4 Asphyxiation Hazards.


 1.5.3 - 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.)


 1.5.3.1 - 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.


 1.5.3.2 - 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.


 1.5.3.3 - 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 4.3.6.1.2.

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 and needle were collected as part of your sample.


 1.5.3.3.1 - RAIL SAFETY

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. The force can knock people down and into the path of subsequent cars.

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. Always have a railroad yardman or another FDA investigator 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.


 1.5.3.3.2 - GRAIN ELEVATORS

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. 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.
  5. Make sure walkways between bins are sturdy.
  6. Use caution when sampling from high bins or tanks. Wet or icy conditions may prevail, so check these conditions.
  7. 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.
  8. Do not use flash units in dusty areas because of the possibility of explosion hazard. See IOM 5.3.4 for additional information.


 1.5.3.3.3 - CLOTHING

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.


 1.5.3.3.4 - TRUCKS

Make sure any truck you enter during sampling and/or inspection will remain stationary while you are in it.


 1.5.3.4 - 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 1.5.4.2.2, 4.5.3.5, and 8.5.3 for additional dry ice cautions).
  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, e.g., where oxygen has been replaced by carbon dioxide to prolong fruit storage, added sulfur dioxide for preservation purposes, etc. These areas must be aerated and deemed safe by the firm prior to entering.


 1.5.3.5 - 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.


 1.5.3.6 - 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 3.2.12 for further information and for the address and phone numbers of the ATSDR contacts.


 1.5.3.7 - 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

Notify the receiving laboratory of sample collection.


 1.5.4 - INSPECTIONS

Many firms pose safety hazards or problems. Some include:

  1. Flying glass in bottling plants
  2. Explosion hazards from dust
  3. Man-lifts which do not operate properly
  4. Asphyxiation problems in rendering plants, fish meal plants, fumigated bins in elevators, fumigation chambers and any closed bins or areas
  5. Forklifts and other power equipment operated in the plant. Be alert for their presence and avoid being hit.


 1.5.4.1 - Man Lifts and Ladders

Many firms have either power or hand driven man lifts for movement between floors. Do not use the man lift if company policy forbids non-employees using them.

Before riding mechanical lifts, make sure safety equipment is installed and operating properly.

When riding power lifts, observe the following safety precautions:

  1. Determine ahead of time what floors are serviced by the lift and at which floor you intend to get off
  2. Determine safety devices, and how they operate. Check lift for automatic cut off at the top or a safety stop cord
  3. Always face the belt when riding the lift
  4. Never carry excess equipment or items that protrude and could get caught between floors.

When using hand powered lifts, remember to:

  1. Check the foot brake for proper operation
  2. Check if control rope is firmly fastened at the bottom
  3. If lift has a stop pin which must be removed prior to use or after use, determine how it is used and use it
  4. Check counterbalance of lift, and add or remove weights if necessary
  5. Never free-fall on the lift when descending; always keep descent in control by using the brake
  6. Use gloves to avoid rope burns or slivers from the hemp or metal pull ropes.

Never over-extend a ladder. If possible, have the bottom held by someone while you are using it. Use blocks on base of portable Grain Car Ladders to hold base away from car wall to provide foot space on ladder rungs.

Some mills and elevators have makeshift ladders. Extreme care should be exercised when using these.


 1.5.4.2 - Factory Inspection


 1.5.4.2.1 - RETORTS

Inspections of retorts require extra safety precautions. Be alert for live steam and other potentially dangerous heat sources. Do not enter a retort if your safety cannot be assured. When it is necessary to enter a retort, inform plant management. The firm must have a confined space policy in place.

Contact your local hygienist or ORA’s National Safety Officer for additional information/training about confined space, which includes Lock-out Tag-out procedures.


 1.5.4.2.2 - THERMAL

When inspecting freezers, make sure doors cannot accidentally snap shut and lock you inside. Be alert to ammonia leaks while inspecting freezing and refrigerating operations. Note: Ammonia under normal operating conditions retains its chemical stability and will not burn or support combustion. An ammonia leak in a freezer can cause explosions if proper air/ammonia mixtures are reached. It can be toxic if inhaled, and can cause eye and throat irritation. If an ammonia leak is discovered during an inspection, leave the area immediately and notify management of the leak. Warning: If an ammonia-contaminated area must be entered, a full-face mask or self-contained oxygen mask or a gas absorbing canister mask must be worn. Protective clothing is also necessary, if the ammonia concentration is high. If you are unable to obtain the use of the mask and protective clothing, then do not enter the area.

Use care when entering areas where large amounts of dry ice are used or stored. Be sure the area is adequately ventilated prior to entering. See IOM 1.5.3.4, 4.5.3.5 and 8.5.3 for additional cautions concerning use of dry ice.

When visiting facilities handling drug products, check with management to determine if any of the articles produced require special handling or protective equipment, such as respirators.


 1.5.4.2.3 - CHEMICAL

When conducting inspections of firm’s using chemicals, pesticides, etc., ask to review the MSDS for the products involved to determine what, if any, safety precautions you must take. This could include the use of respirators or other safety equipment.

Ethylene Oxide (EO) - EO is a colorless gas or volatile liquid with a characteristic ether-like odor above 500 ppm. Unmonitored and inadequate ventilation will allow EO buildup of extremely high concentrations, especially in facilities utilizing 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 EO is detected, ventilation and containment are inadequate. Leave the area and report the situation to your supervisor for further inspectional guidance. Special EO monitoring equipment is available upon request from the Office of Regulatory Science’s National Safety Officer for investigators' safety monitoring of inspectional site.

OSHA standard regulating employee exposure to EO is presently 1 ppm over an 8-hour day. You should avoid all unnecessary and preventable exposure to it. This gas has toxic (including possible cancer and reproductive hazards), flammable and explosive properties, and must be used and handled with caution. Adhere to any procedures the firm has established for protection of personnel from over-exposure to EO. Where improper venting procedures or defective equipment are observed, take adequate precautions, i.e., do not enter potentially hazardous areas, and/or wear protective clothing and a respirator. Refer to IOM 1.5.1. 29 CFR 1910.134 contains basic requirements for proper selection, use, cleaning, and maintenance of respirators.


 1.5.4.2.4 - IONIZING RADIATION

Each investigator who visits a manufacturer of radioactive products or tests ionizing radiation emitting products (e.g., diagnostic x-ray tests) must wear a Thermoluminescent Dosimeter (TLD) to estimate external exposure. These are available in each district; personal alarm dosimeters are also available. These can alert the investigator to high exposure areas during visits to manufacturing firms. Make an estimate of the time spent in areas where radiation is present, and estimate exposure during this time from your personal dosimeter. The estimate can be compared to the results from the TLD badges, which would be processed by Winchester Engineering and Analytical Center (WEAC). Contact WEAC for additional information concerning TLD badges.

Experience has shown there is a potential for internal exposure from inhalation of radioactive material, especially in the case of iodine isotopes. Ingestion of radioactive material from contaminated notebooks, workpads, etc. is also possible.

When you are inspecting radiation-emitting devices and substances, take every precaution to avoid undue exposure or contamination. Time, distance, and shielding are important when working around radioactive materials. Adhere to the firm's established safety procedures and precautions. Where employees are required to wear protective apparel, eyeglasses, or monitoring equipment, follow those procedures. Use protective gloves to avoid hand contamination when handling the lead pigs containing radioactive materials.

Monitoring devices must be used whenever exposure is possible. Monitoring equipment must be calibrated periodically in order to be accurate. There are a variety of meters that can be utilized for radiation protection. Film badges are usually used to determine accumulated amounts of radiation, and unless these are analyzed the exposure dosage is unknown. This will be done by WEAC. Dosimeters will provide a reading at the time of exposure.


 1.5.5 - MICROBIOLOGICAL HAZARDS

When processes involve potential for microbiological contamination, normal controls and procedures should contain or protect against any possible hazards. The procedures may include routine use of protective clothing and equipment. Precautions mentioned below concerning gowning, masks, gloves, etc., in this section, are also important in the event that accidents, spills or unexpected, uncontrolled contamination occurs while you are in work areas. If contamination is known in advance to be uncontrolled or you must handle contaminated materials, do not enter an area or handle these materials without first consulting with your supervisor.


 1.5.5.1 - Animal Origin Products

Caution: It may be necessary to wear gowns, masks, rubber gloves, etc., when inspecting some of these work areas. Be guided by how the firm's employees dress for their work areas, and dress accordingly. Consult with the firm's management and your supervisor regarding dress and precautions to follow.

When inspecting manufacturers, or collecting samples of animal origin products, be alert for possible routes of contamination that could lead to your injury or illness. Some possible vectors of disease exist in firms that process products which use animal origin products as raw materials. They include:

  1. Anthrax - Care must be taken during inspections of processors of bone meal, dicalcium phosphate and gelatin.
  2. Tularemia - Use caution when inspecting rabbit processors. Be careful of scratches from bone splinters. Use gloves for protection.


 1.5.5.2 - Viral and Other Biological Products

Take proper precautions to protect yourself. If necessary, consult your supervisor and/or district microbiological personnel. NOTE: Inspection of vaccine manufacturers may require inoculation in advance of the inspection to adequately protect the investigator. Contact the Center for Biologics Evaluation and Research (CBER), Division of Viral Products, HFM-445, for guidance.

Methods of transmission include aerosols, which may be created by manufacturing operations (e.g., centrifugation, filling, etc.) or spills. Transmission may occur through inhalation; contact with contaminated objects, including equipment, animals, waste materials, reagents, file cabinets and doorknobs. Transmission can occur through ingestion, inhalation, or through broken skin.


 1.5.5.2.1 - PROTECTIVE AND PREVENTIVE MEASURES

Protective and preventive measures include:

  1. Precautions listed in IOM 1.5.5.1 and 1.5.5.3
  2. Do not touch. This means equipment, materials, reagents, animals, etc.
  3. Wear protective clothing. Evaluate the needs for gowns, caps, masks, gloves, and shoe coverings, and wear them where necessary. Protective clothing worn in a work area where a virus or spore bearing microorganism is handled must not be worn into a work area for another product. Leave all used protective clothing at the firm for proper disposal.
  4. Wash hands thoroughly after leaving each work area.
  5. Determine if the firm has established safety precautions and procedures, and follow them if adequate.
  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. Females of childbearing age are advised not to inspect areas where the Rubella virus is actively processed unless immunity has been established. Infection during pregnancy may result in congenital abnormalities.
  8. Vaccines are available for your protection against some organisms (e.g., Rubella). For information on inoculations and physical examinations, refer to IOM 1.5.1.5.


 1.5.5.2.2 - VIRAL HEPATITIS AND HUMAN IMMUNODEFICIENCY VIRUS

Precaution - Blood and Plasma Inspections - Viral Hepatitis and Human Immunodeficiency Virus (HIV) - the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Be alert around blood banks or blood processing operations to the possible dangers of these and other infectious agents.

Keep in mind the following warnings:

  1. Do not touch. This means 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 best. These should be left in the laboratory area.
  2. Do not smoke, drink, eat or have meetings in the blood banks or in the testing areas for Hepatitis B Surface Antigen (HBsAg), HIV, or any other infectious agents.
  3. Consider blood samples, the antigen and antigen testing kits and other associated HIV, HBsAg, and other test reagents as potentially infectious.
  4. 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 lab areas. Wash hands thoroughly after these inspections. Hepatitis can be transmitted by hand to mouth.
  6. Use disposable gloves. Spills may be wiped 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, etc. occur in your presence, you are not required to participate in cleaning or disposing of materials. This is the firm's responsibility.
  7. Use scrupulous personal hygiene at all times in the blood bank and in the testing areas for HBsAg, HIV, and other infectious agents.


 1.5.5.2.3 - PRECAUTIONS FOR NON-CLINICAL LABORATORY INSPECTIONS

Precaution - Non-Clinical Laboratory Inspections - During inspections/investigations of sub-human primate facilities (e.g., Good Laboratory Practices (GLPs), non-clinical laboratory testing facilities, animal holding facilities, etc.) do not enter rooms housing sub-human primates. Monkeys normally housed in these facilities can carry "Herpes-B Virus", "Simian B Virus", or "monkey-virus". During inspections of this type, use the following guidance:

  1. Investigators shall not enter any rooms which hold or house subhuman primates. Bioresearch monitoring (BIMO) inspectional information should be derived from personnel interviews and record examinations conducted outside of the primate areas.
  2. All study records usually found in the monkey rooms (Standard Operating Procedures (SOPs); protocols; animal housing, feeding, handling, and care records; animal isolation and health records, room environmental records; dosing and animal I.D. records; animal daily observation records; equipment and room cleaning records, et al.) should be reviewed outside of the rooms.
  3. Although contact with subhuman primates in the course of an inspection is prohibited, information on animal room activities may be obtained through personnel interviews.


 1.5.5.3 - Bacteriological Problems

Take proper precautions to protect yourself. If necessary consult with your supervisor and/or district microbiological personnel. Possible routes of salmonellosis include dust inhalation in dried milk and dried yeast plants. Thyroid processing plants may also be a source of this problem.

In no case should you taste any item implicated or suspect of causing injuries or illnesses (e.g., consumer complaint samples, etc.). Handle these with extra care since even minute portions of certain items may cause serious illness or even death (See IOM 8.3.3).


 1.5.5.4 - Hantavirus Associated Diseases

Rodents and other small mammals have been identified as the primary hosts for recognized hantaviruses. Infected rodents shed the virus in saliva, urine and feces. The time of this virus' survival in the environment is unknown.

Human infection may occur when contact is made with infected saliva or excreta, through inhalation of aerosol produced when the animals sneeze, or contaminated dust particles are stirred up. In addition, infection can also occur when dried contaminated materials are disturbed and directly introduced into broken skin or onto the conjunctivae.

Hantaviruses can present some or all of the following symptoms: fever, headache, muscle aches, nausea and vomiting, chills, dry cough, and shortness of breath.

Investigators/Inspectors may be subject to an increased risk of infection because of unpredictable or incidental contact with rodents or their habitations, i.e., entering various buildings, crawl spaces and other sites that may be rodent infested.

When encountering or suspecting rodent infested areas, the following protective and preventive measures are recommended:

  1. First and foremost, DO NOT HANDLE RODENTS - DEAD OR ALIVE.
  2. Be careful when moving items around, excessive dust may increase the risk.
  3. To prevent eye contamination, wear goggles or a full-face respirator.
  4. High-Efficiency Particulate Air (HEPA) filter masks or respirator cartridges are recommended to avoid inhalation of aerosols. Because of the minute size of the virus, dust masks will likely not filter out the organism.
  5. Wear coveralls, and handle and dispose of as infected material.
  6. Wear disposable latex or rubber gloves. Be careful to avoid hand contamination when removing gloves. Wash hands thoroughly after removal.
  7. In addition to these measures, follow any guidance issued by state health departments.

Anyone who develops a febrile or respiratory illness within 45 days of the last potential exposure should immediately seek medical attention. Inform the attending physician of the potential occupational risk of Hantavirus infection.


 1.5.6 - WIRELESS DEVICES

The following information is provided regarding the use of wireless devices: 

  1. If you carry a blackberry, cell phone, or other wireless device, always enquire about a firm’s policy with regard to their operation within the establishment as they may pose a safety hazard. 
  2. An Executive Order, signed by President Barack Obama and issued by the White House on October 1, 2009 prohibits federal employees from engaging in text messaging while driving GOVs, or POVs while on official business, or using government provided electronic equipment, e.g. blackberry, while driving.
  3. FDA policy prohibits the use of hand held wireless phones or other wireless devices while operating government, commercially leased/rented vehicles.  Drivers who use cell phones within their scope of work are required to use hands-free cell phones and other hands-free devices.


 1.5.7 - REPORTING

Automobile Accidents - See IOM 1.2.2.2 - Accidents, for procedures.

Injuries - If you are injured during the performance of official duties, report immediately to your supervisor. If medical aid is required, obtain it as soon as possible. Check with your supervisor on what accident report forms are required and procedures to be followed.