Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 8.5 - DISASTER PROCEDURES
- 8.5.7 - PRODUCT DISPOSITION
- 126.96.36.199 - Segregation
- 188.8.131.52 - Destruction
- 184.108.40.206 - Reconditioning
- 220.127.116.11 - Relabeling
- 18.104.22.168 - Ammonia Leaks
- 22.214.171.124 - Perishable Products
- 126.96.36.199 - Reconditioning Plastic, Paper, Cardboard, Cloth and Similar Containers
- 188.8.131.52 - Reconditioning Screw-top, Crimped-cap, and Similar Containers
- 184.108.40.206 - Reconditioning Hermetically Sealed (Top & Bottom Double Seam) Cans
- 220.127.116.11 - Reconditioning Devices
The objective of FDA investigations in the aftermath of non-attack disasters is to determine whether or not foods, drugs including biologics, cosmetics and devices affected by the catastrophe are safe for human and animal use; and if not, to effectively remove them from commerce.
In disaster operations, FDA will assist state, local and other federal agencies in removing contaminated or unfit merchandise from the market.
The types of natural and man-made disasters which affect FDA operations are:
|Wrecks||Riots and Disorders|
State and local officials usually assume direct responsibility, as their laws and regulations can be immediately invoked, however FDA assistance is often requested. Except in unusual circumstances, FDA responsibilities are to assist the state and local health agencies in removing, destroying, or reconditioning affected merchandise.
In situations involving interstate movement of merchandise; large interstate firms; areas in which state or local political ramifications are anticipated; or when state or local health officials so request; FDA may assume the primary role in the operation.
Personal Safety - In a disaster or pending disaster the personal protection of yourself and your family is your primary concern. Provide for your own safety as you perform your FDA duties in a disaster area. Inoculations and protective clothing should be considered. See IOM 1.5.1 and 18.104.22.168.
Disasters produce dangerous situations (e.g.; high water, escaping gases, fallen electrical lines, damaged buildings, falling rubble, etc.), so care and extra safety precautions must be observed. If you become sick or injured, you become another problem to already overworked health officials.
CAUTION: In situations where electrical power has been out for an extended period of time, and firms attempt to salvage frozen or refrigerated products using dry ice; do not enter these areas without first providing for proper ventilation and/or obtaining oxygen breathing apparatus.
Inspectional and Investigational Preparation - After taking care of yourself and family, and being properly equipped and supplied, you are ready to begin disaster operation. Stock your car in the same manner as for any inspectional activities; however, consider the extra amounts of materials needed in the particular situation.
Extra gasoline and oil, drinking water, communication equipment (cellular and satellite phones, email, etc.), battery powered radios, lighting equipment (battery flashlights, propane or gasoline lanterns, etc), extra film, medical supplies and materials of an emergency nature must be provided if power facilities and normal distribution channels are disrupted. Consideration must also be given to your own sleeping and eating needs.
Review the Model Food Salvage Code, 1984 Recommendation of the Association of Food and Drug Officials and the U.S. Department of Health and Human Services for guidance.
Initial Information - FDA usually learns of disasters, or impending disasters from weather agencies, news media, public health agencies, civil defense units, or law enforcement organizations. Initially, there is little anyone can do, other than monitor the course and severity of a disaster, until the situation becomes sufficiently stabilized for personnel to move into the area to survey damage.
Initial Procedures - FDA's initial course of action is to contact state and local officials, offer assistance, and begin to coordinate the mobilization of personnel and resources necessary to handle the emergency.
If you are in an area when a disaster strikes or is imminent, advise your supervisor on the situation by the fastest means possible. In the initial stage of the operation you may be the only FDA representative on the scene. If this is the case, contact the state or local officials and offer your services, advising them you have alerted or will alert your district as soon as possible. Keep your supervisor informed.
Each district has a disaster plan which will be implemented in applicable situations. As the situation develops, you will receive instructions from your supervisor.
Inspectional and investigational activities will normally be conducted with other FDA personnel and state or local counterparts.
Once personnel are mobilized and assignments issued, your operational procedures will be similar, regardless of the type of disaster. You will be searching out, identifying and investigating foods, drugs, devices, and cosmetics for actual or possible contamination and taking the necessary steps to preclude their use until they are released, reconditioned, or destroyed.
A rapid physical survey must first be made of the disaster area to determine the extent of damage, and the amounts and kinds of merchandise involved.
CAUTION: Although procedures in this subchapter do not cover disasters resulting from nuclear attack, it is possible you may discover products suspected of contamination by radioactive materials in the disaster area. If you suspect the presence of radioactive materials, take no action on the materials yourself, but have the area cordoned off at once. Notify the command official and immediately contact your supervisor to alert the regional radiological health representative and the state radiation control agency. Follow their instructions.
When in doubt as to the condition of any materials affected, request holds or embargoes pending final outcome of further examinations. See IOM 22.214.171.124.
FDA does not have embargo authority. However, FDA does have administrative detention authority as specified in:
- The Federal Meat Inspection Act
- The Poultry Products Inspection Act
- The Egg Products Inspection Act
- Certain parts of the FD&C Act, namely Section 304(g) [21U.S.C.334(g)] for medical devices and section 304(h) [21 U.S.C. 334(h)] for human and animal food
FDA has administrative detention authority for medical devices, FD&C Act Section 304(g), and food, FD&C Act Section 304(h), when FDA has reason to believe that the article is adulterated, misbranded, or presents a threat of serious adverse health consequences to humans or animals.
In an instance where embargoes are warranted, Districts should work with their state partners to determine their embargo authorities. State and local authority embargoes are an effective tool for keeping adulterated and misbranded product from the consumer market. State and local embargoes can be employed immediately requiring the merchandise held, destroyed, or reconditioned without time consuming delays. Some state and local embargo powers are limited as to the length of time product can be embargoed and a minimal quantity or value. In these cases, the use of federal administrative detention, injunction and seizure action should still be considered. Discuss embargo authorities and timeframes with state or local agencies for the duration of the emergency.
During all your investigational activities, examine the lots affected for obvious adulteration, decomposition, contamination, or physical damage. Use your camera extensively, and collect samples whenever indicated. Judge the extent of field examination and sample collections necessary, based on the nature and magnitude of the disaster.
In major catastrophes, large numbers of samples may not be necessary because of obvious visible contamination and the emergency disposition powers invoked by state and local officials. In minor local disasters, such as fires, riots, train, truck, or shipwrecks, lots may be held pending outcome of examinations, so extensive sampling may be required.
Examine cans or jars for physical damage (rusty, burst seams, holes, ripped, etc.), and for visible adulteration from filth, oil, or chemicals, and damage to the product's labels (defaced labels). In addition, examine jars and bottles for sediment or other visible filth under cap crimps and cap lugs. When a lid is removed, sediment or micro-contamination may be drawn into the container by internal vacuum. Discard any jars you open for examination. Visible contamination under lids may be photographed or lids may be used as exhibits as conditions permit.
Plastic, paper, cloth bags, and cardboard containers must be examined for physical damage and contamination.
Stocks of devices must be examined for contamination and water, heat, mechanical, physical, electrical, or chemical damage. If any doubt exists as to whether or not devices have been affected, experts should be consulted or utilized.
Examine bulk containers and their contents, including underground storage tanks. Examine material in rail cars, truck trailers, and storage silos. Be especially alert for rail car and trailer movement. These quickly disappear, as clean-up crews arrive.
All flood water, regardless of its source, must be considered a polluting medium because of overflowing sewers, outhouses, decomposing livestock, street run-off water, etc.
Depending on the extent of the flood, first determine the locations of the major stocks of regulated products. Food and drugs will normally receive first priority. As stocks of goods are located, rapidly survey the extent of damage, then concentrate on affected materials. Use your camera extensively. Examine the walls of buildings and storage areas and the top and sides of stacked or tiered goods for flood water residue, debris, and the usually well defined high-water mark. Finished products, ingredients, and containers stacked above this line are still of concern because other problems probably exist (e.g. vermin defilement, failure of refrigeration, thawing of frozen items, etc.).
Make arrangements to have any suspect material embargoed by local officials, or held pending final disposition. Management is usually cooperative and willing to do things it may not normally do to get back to normal operations as quickly as possible. Cooperate with management, but avoid hasty decisions.
Many products are quickly rendered unsuitable for human consumption by water action. Items such as bread, cakes, cookies, candies, bulk flour, sugar, bulk liquids, and similar items not in jars or hermetically sealed containers can often be immediately hauled to disposable areas and destroyed.
Determine areas which have lost power. In facilities such as frozen food firms, frozen or refrigerated warehouses, etc., check the sites for length of down-power and condition of the products. If power is restored in time to avoid thawing, or prevent spoilage of refrigerated items, and products were not inundated, or otherwise affected, there is no need for further examination.
Even though flood waters may not have inundated the firm, the situation may have caused sewer and waste lines to back-flush into basements and immediately drain out again. Debris or sewage particles along walls and on low floor surfaces or presence of sewage odors are evidence of backflushing.
Grain, cottonseed, soybeans, dried bean products, peanuts, and similar products may become flood damaged in terminal elevators, on farms, and in flat storage facilities. In addition to flood water contamination, molding products may develop mycotoxin contamination. Examine susceptible products and facilities for damage, inundation, and mold.
Rodent activity may increase in flooded areas as the vermin seek food and shelter. Be alert to rodent defilement on products.
As lots of products are checked, embargoed, or released and the immediate situation returns to normal, firms will want to start operating. Prior to their beginning operations, examine equipment and processing facilities for pollution, and its aftermath. Plant operation must not be permitted unless proper cleanup and sanitizing is performed.
Investigate following the guidance in IOM 126.96.36.199. In addition, examine products for evidence of physical damage caused by flying particles and crushing by debris. Physical damage to product containers may be extensive. Broken or leaking containers of materials such as chemicals, oils, fertilizers, etc., may have contaminated materials subject to FDA coverage. Also see IOM 188.8.131.52 on chemical contamination from various sources.
FDA operations following these disasters are usually localized and do not normally involve a large number of personnel or extended resources.
Examine products for exposure to excessive heat, physical damage from flying particles and falling debris, and lack of refrigeration in down-power areas. Examine for water damage from fire fighting activities and handle these as a flooding situation. Also, be alert for possible pollution from using non-potable water in fire fighting.
Fire fighting often involves use of chemicals, so examine products for residues from possible toxic fire extinguishing materials, and question fire authorities regarding this issue.
In addition, chemical contamination in fire disasters can also be present from other sources, including:
- Stored chemicals rupturing from heat or from impact of falling debris;
- Spraying or leaking chemicals (liquid, powder, dust, granules) as damaged containers are being removed or salvaged from the fire area;
- Tracking of chemical material from contaminated areas to other areas by fire crews or others;
- Burning or melting plastic containers, insulation, and other building materials;
- Leaking fuels, storage batteries, anti-freeze, etc., from burning, damaged or overheated equipment;
- Chemicals from melting or vaporizing electrical insulation and, in particular, cooling chemicals from leaking or exploding electrical transformers. Large commercial transformers are often directly involved in the fire area and may leak or explode from the heat, spreading toxic liquid chemicals (some transformer oils contain concentrations of PCB) over a large area, even contaminating products in non-fire areas.
See IOM 3.2.11 for information.
Chemical spills occurring on land or water can pose a serious threat to the environment and contaminate FDA regulated products both directly and indirectly.
In wrecks, the physical impact usually causes most damage. Toxic items in the same load may rupture and add to the contamination. In train wrecks, other railcars loaded with chemicals, oils or other contaminating materials may rupture and contaminate food and drug products in otherwise undamaged cars. Removal of the wreckage may cause further physical damage or chemical contamination. Exposure to weather may also adversely affect the products.
Do not overlook the possibility that runoff of toxic chemicals from wrecked and ruptured cars may contaminate adjacent or nearby streams supplying water to downstream firms under FDA jurisdiction.
Hazardous waste sites also pose a hazard to the immediate environment, as well as off-site, if runoff contaminates nearby surface waters or if leachate contaminates ground water supplies.
Extreme care must be exercised when working in earthquake areas. Do not enter severely damaged buildings.
Most damage from an earthquake comes from the after shocks, falling debris, and resulting fires and flooding. Items under FDA jurisdiction are most likely to suffer physical damage, spoilage from lack of refrigeration, and/or fire and flood damage.
Guidance to the Field on Bioterrorism (10/17/2001)
When a District is notified of a suspected bioterrorism event (including anthrax events) involving an FDA regulated product, they will notify Office of Crisis Management/Office of Emergency Operations (OCM/OEO) (301-796-8240) and the local OCI office immediately. OCM/OEO will then notify the appropriate FDA Center, the HHS Office of Emergency Preparedness (OEP) and OCI headquarters. OCI will then notify FBI and/or local law enforcement. If OCM/OEO or any other FDA office gets a report, OCM/OEO will notify the offices above as well as the District Office involved. Notification of the state officials will occur at the direction of OCM/OEO or OCI.
It is vital that the person taking the initial report obtain complainant contact information as well as detailed information about the event. This is the same information that is regularly collected for consumer complaints and used to record the complaint in FACTS. Complainants should be instructed to call local police (911) and follow police instructions.
If a bioterrorism act is suspected, FDA staff should not collect or accept samples from any local, state, or law enforcement agency as such actions will be coordinated by OCI and the FBI, as appropriate. If an FDA product is suspected in a tampering, please call OCM/OEO immediately. In the event that FBI/OCI determines the product is not suspect, OCM/OEO will issue further guidance to the District Office.
In every disaster situation orderly disposition of affected merchandise poses problems. Lots under embargo, or voluntarily held pending examination or analysis, must be secured until the examination or analysis is completed, and a decision to release is made. If the material can be released, it is returned to the owner. If contamination is obvious and state or local officials condemn the lots, arrangements must be made for disposition. Mixed adulterated and non-adulterated materials must be held for segregation and disposition.
Depending on the circumstances and the magnitude of the disaster, segregation, destruction, or reconditioning of affected goods may be accomplished in the immediate area. However, the materials may be moved to distant locations for further manipulation.
FDA normally opposes movement of affected goods since control of the lots is difficult. However, in cases of wide spread disasters, reconditioning centers established in non-disaster areas may be the most efficient way to handle the problem. Decisions of this nature will be made by command or headquarters officials. Should the materials be moved, arrangements must be made for their control. Short moves might necessitate guards on the vehicles to prevent diversion, while longer ones may be by regular carriers with control by shipping records, sealed railroad cars, bonded truckers, etc.
A situation not usually encountered during our normal operations is the problem of scavengers. Handling scavengers and preventing their activity is a police matter. Nevertheless, it ties in closely with your operations in disasters, and plans must be formulated for the protection of products detained, released, or awaiting disposition at the disposition site.
In disasters, local police forces are usually augmented by State and County Police, National Guard, State Militia, or private security forces. Arrangements should be made by the disaster command officials for guarding of affected products. If this has not been done, you should make the recommendation.
The condition of certain products may be difficult to ascertain since one often has no way of determining how excessive heat, humidity, or disaster conditions affected packaged contents. Smoke damaged containers of one material may not be of concern, while for other materials; it may be cause for condemnation. Rules for each product in each situation are impossible. Your decisions in disaster areas should be based on experience, review of the laboratory results if possible, and input from your state/local counterparts and superiors.
The segregation process often creates a multitude of problems, especially when insurance claims-agents and salvage firms become involved. You are not to segregate materials yourself. This is the responsibility of the owner or his agent. You should advise them what constitutes releasable conditions. After segregation, you may be instructed to advise them what can and cannot be released based on your examination and/or laboratory results.
It is not your responsibility to say how condemned products are to be destroyed. This is a concern of the owner and the state or local health agencies that condemned the products. Many times, however, FDA will be asked to aid in or recommend destruction methods. The most common destruction method is crushing and dumping in a land fill in approved areas. See IOM 2.6.1. Destruction methods usually are worked out with state or local officials. The final decision in major operations may be required of the command officials or higher headquarters, especially if the environmental impact is significant.
Control products to be destroyed and protect them from pilfering at destruction sites.
Often, products affected may be reconditioned depending on the condition of the product, its container, type of product, intended use, and extent and type of contamination.
Any reconditioning must be closely supervised, with proper safeguards for product accountability. Procedures must be such that control is maintained over the complete operation, with proper disposition of the rejected portion and the reconditioning of the acceptable portion performed to the satisfaction of all health officials.
Certain products which cannot be salvaged for human or animal use might be of use in non-food or non-feed industries. Examples of such products include:
- Butter for soap stock
- Meat and Poultry products for technical oil production
- Oils and nuts for technical oil production
- Flour for glue or wall board construction
- Grains and fruits (especially dried) for industrial alcohol
- Fish for fertilizer
- Eggs for tannery use
However, these must be denatured to render them unfit for food or feed use. Firms must account for the amounts of product denatured, to whom it was sold, and the final use of the product. Examination of the product at its final destination and/or a spot check may be required to assure it is utilized in non-food or non-feed products.
Relabeling will be permitted, if all the following conditions are met:
- The new label contains all mandatory information, is not misleading in any way, and conforms with the Act in all other aspects;
- Label codes are carried over to the new label;
- The product is not contaminated; and
- The container has its original integrity.
Refer to IOM 184.108.40.206.3 for guidance prior to entering any area where an ammonia leak has occurred.
If products involved in an ammonia leak are to be salvaged or reconditioned, cover the following points:
- Cases of food should be removed from ammonia spill rooms as soon as possible;
- Food packages should be removed from master corrugated cases as soon as possible. Ammonia appears to be absorbed by the corrugated cases;
- Food products should be repacked into unaffected cases and moved to storage areas free of ammonia and other products;
- When sampling ammonia contaminated products use IOM Sample Schedule Chart 3 for guidance.
The following barrier characteristics of packaging materials exposed to ammonia will help in deciding if food products may be salvaged or reconditioned:
- Kraft and other types of paper are very permeable;
- Plastic films (polyethylene, saran, cryovac, etc.) are relatively good barriers;
- Water glaze (ice) on food will absorb ammonia and the washing action by melting ice may eliminate ammonia;
- Waxed paper overwrap and waxed cardboard boxes are very permeable;
- Loose packed Individually Quick Frozen (I.Q.F.) Foods are more susceptible than block frozen foods;
- Glass, metal and heavy aluminum foil packages are excellent barriers.
Milk is extremely perishable, and is highly susceptible to bacterial contamination. Any attempts at salvaging milk are risky. Retail cartons of milk are not to be salvaged. Storage vats or sealed tanks of milk in processing plants must be closely examined and tested before release. If milk has been affected by flood waters, it should be condemned.
Fresh fruits and vegetables which have been inundated by flood waters cannot be adequately cleaned. Most are subject to rapid spoilage.
Products which require refrigeration or freezing and that have been immersed in flood waters cannot be reconditioned. The same applies to meats or poultry which have been without refrigeration and may be in a state of decomposition.
The following is general guidance in determining when frozen or refrigerated products cannot be reconditioned:
- Products that are contaminated;
- Products that have thawed and there is evidence of decomposition;
- Products that have thawed and represent a potential public health hazard;
- Products that have not been maintained at temperatures appropriate to individual product requirements;
- Products meeting criteria in the proceeding sections regarding types of containers.
Products packed in plastic, paper, cardboard, cloth and similar containers that have been water damaged usually cannot be reconditioned. (In some instances, sugar has been permitted to be returned to a refinery for reprocessing, but each case must be decided individually). Fire and/or smoke damaged pre-packaged products may be permitted to be relabeled if the contents have not been affected.
General rules for reconditioning of products in these types of containers are the following:
- The product is not contaminated and the product is not highly susceptible to bacteriological contamination;
- If the external container is torn, the interior liner must be intact, and the external container must be repaired or replaced to eliminate possible contamination of the product;
- Soiled containers may be cleaned, if the product is not damaged and the container can be cleaned;
- Foods from torn packages, where the product has been exposed but not obviously subjected to contamination, may be repackaged;
- Water, chemical or other liquid damage, where the exterior package may be replaced, providing the internal containers were not affected and the external containers can be replaced without contaminating the product;
- Fire damaged products (e.g. wet, burned, heavy smoke or toxic fume contamination), are generally not reconditionable.
NOTE: Foods for infants, the aged or infirm, and drug products must be strictly controlled to assure the product is acceptable.
Products in containers with screw-caps, snap-lids, crimped-caps (soda pop bottles), twist-caps, flip-top, snap-open, and similar type closures must not be reconditioned. Sediment and debris from flood water becomes lodged under the cap lips, threads, lugs, crimps, snap-rings, etc. and is impossible to remove, especially after it has dried. If these container/closure systems are affected only by fire or smoke, but the contents are not affected by the heat, they may be relabeled.
General rules for reconditioning are:
- Product is not contaminated, or rendered unfit for food.
- Soiled containers may be reconditioned if soil can be removed, and it does not involve the closure or contents.
- Rust on closure: No rust allowed; surface rust may be removed by buffing or other suitable means.
- Cap or crown dents: slight indentations obviously not affecting the rim seal would be reconditionable.
- If there is evidence of exposure to extreme temperatures or pressures (hurricanes-tornadoes), products are not reconditionable.
- If there is soil around the closure, products are not reconditionable.
- If submerged in water, chemicals, or other liquids, products are not reconditionable.
- If container/closure is defective or not properly sealed, products are not reconditionable.
Products in this type container which have been exposed to fire and smoke, and which are not damaged by the heat or exposed to water contamination, may be relabeled.
This type container, having been immersed in water, may be reconditioned and relabeled under controlled conditions and supervision as follows:
- Inspect cans;
- Remove labels;
- Wash containers in soap or detergent solution, brushing as necessary;
- Rinse in potable water;
- Buff to remove rust. Heavily rusted cans are to be discarded;
- Disinfect by:
- Immersion in a solution of sodium hypochlorite containing not less than 100 ppm available chlorine or other equivalent disinfectant, or
- If product will stand it, immerse in 212°F water, bring the temperature of the water back to 212°F and maintain the temperature at 212°F for at least five minutes, then remove and cool to 95°F;
- Dry thoroughly; and
General Rules for reconditioning canned foods are:
- The product is not contaminated.
- No rust is allowed. Surface rust may be removed, by buffing, electrolysis, or other suitable means.
- Cans soiled by dirt, smoke, etc., may be reconditioned if the product is not contaminated and the container can be cleaned by an acceptable method.
- Water contaminated cans may be reconditioned if subjected to an approved bactericidal treatment and dried promptly.
- If can dents consist of insignificant paneling or slight dents not affecting the double seam, or cracking the can corrugation, and not causing the can end to bulge, reconditioning is possible.
- Leaking cans, cans with open seams, severely damaged seams, cans which are abnormal (i.e., swollen or flipper) and cans with defective closures are not reconditionable.
- Cans exposed to extreme temperatures are not reconditionable.
- Cans crushed to the point that the can body is extensively creased, paneled or dented on the seams can not be reconditioned.
Radiation Type Devices - Radiation producing products such as x-ray equipment, TV sets, and microwave ovens are relatively complex, expensive, sensitive devices. Any of these type devices which have been inundated by flood waters, exposed to fire, heat, mechanical or physical damage such as falling debris, chemically corroded, or electrically damaged must be checked by expert personnel. They will decide whether the device can be repaired or reconditioned by the manufacturer and/or re-tested for compliance.
Do not release any of these type devices, but report the situation to your supervisor so arrangements can be made for appraisal. The regional radiological health representative will normally be the individual contacted by your district in this type situation.
Medical Devices and Diagnostic Products - Do not attempt any reconditioning of these type products.
Any medical devices or diagnostic products which have been affected by disaster forces should not be released. Advise your supervisor of the facts so the district officials can obtain any necessary advice and guidance from the Center for Devices and Radiological Health.
See IOM 1.1 English language requirement. There is no prescribed format for narrative reporting of disaster operations. Consult with your supervisor as to your district's preference. The report should briefly describe the onset of the disaster, its magnitude, and your activities. Include cooperation with officials, planning operations, and the logical sequence of your activities.
Your report must contain exhibits consisting of photographs, diagrams, records, references to samples, and any other items necessary for proper presentation of the operation. Refer to RPM Chapter 8 "Emergency Procedures," for guidance on reporting natural disasters and civil disorders. Attach copies of any FDA forms issued, especially the use of FDA-2809 (exhibit 8-12), Natural Disaster Report, listing amounts of materials destroyed and the method of destruction. See IOM 2.6.4. Prepare charts and lists as necessary to provide documentation of all affected lots destroyed, reconditioned, or released. Include kinds and amounts of materials segregated, released, reconditioned, and destroyed and method of reconditioning and/or destruction.
Record operation and time in FACTS.