Food additives are defined in section 201(s) of the Act and may not be used in food unless approved by regulation, codified in 21 CFR Parts 172 and 173. However substanceswhose use is generally recognized as safe (GRAS) are not food additives (legally), although they may be food ingredients. GRAS substances do not require premarket approval by FDA. Some, but not all, GRAS ingredients are listed in 21CFR Parts 182 and 184. Before concluding that a substance is an unapproved food additive consideration must be given to whether its use may be GRAS, or whether its use was approved by FDA or USDA prior to 1958 (prior sanctioned ingredients which are also exempt from food additive status).
Food Chemical Codex (FCC)
FCC is a compendium of specifications for food ingredients. It has been issued and revised in several editions and supplements. Several food additive and GRAS regulations incorporate one or more editions of FCC by reference (see 21CFR 170.30 (h) and individual regulations). When incorporated by reference, these specifications are binding and must be met. Where FCC specifications are not explicitly referenced, they are not binding, but serve as a guide for food grade quality consistent with good manufacturing practice.
Additive Processors or Users
The food additives industry has three levels that require FDA review. These are:
- Primary Manufacturer - firms that synthesize or manufacture additives (Codex products).
- Secondary Manufacturer or Mixer (Formulators) - firms that compound premixes containing the additive(s) for specific industries.
- Finished Food Processor (User) - firms that incorporate the additive as a component of finished food.
Special Types of Additives
Because of special problems associated with the following types of additives, they will be excluded from routine inspectional coverage unless your assignment or supervisor directs otherwise.
- Packaging materials
- Waxes and chemicals (other than "economic poisons") applied to fresh fruits and vegetables
- Food additives in feeds
While the above substances are excluded from routine coverage during inspections of food manufacturers, be alert to any unusual use which may be illegal.
Food Additives Status List (FASL)
IOM Appendix A contains an alphabetical listing of substances published in the Federal Register which may be added directly to foods or feeds, and their status under the Food Additives Amendment, Sec. 409, and Food Standards, Sec. 401, of the Act. A few unauthorized or illegal substances not published in the Federal Register are also included. Give substances listed as "ILL" or "BAN" in the FASL, top priority. Additives listed in Subpart F of the Food Additives Regulations are not included. Because entries are abbreviated, you should refer to the regulations themselves for labeling and other requirements.
You will at times encounter substances not included in the FASL. Such substances are:
- Safe substances not on the GRAS list; such as, salt, cane sugar, corn syrup, vinegar, etc.
- Substances in the "grey" area including those:
- For which a petition has been filed but no regulation, including extensions, has been published.
- Granted prior sanction for a specific use in correspondence with the Administration prior to enactment of the Food Additives Amendment.
- Since the list is not all inclusive, substances not listed may, or may not be, authorized by food additive regulations for use.
In addition to the instructions and information provided in IOM Subchapter 530 and IOM Appendix A - Food Additive Status List, direct attention to the following areas when inspecting food additive manufacturers.
For each Food Chemical Codex product produced ascertain foods in which the products are to utilized and identify other projected uses (e.g., premixes, etc.).
Evaluate specifications for food additives and criteria used to distinguish between food grade and technical grade products.
Evaluate in-process controls to assure that additives meet specifications.
Review test results and data summaries that document the safety of the additive.
Evaluate controls to assure compliance with Codex specification such as:
- Chemical tests, purity, physical tests
- Required packaging, if any
Evaluate labeling controls to maintain product identity, i.e., prevent cross-contamination and product mixups.
Determine if an additive is recommended for use in standardized foods where the additive is not permitted.
Obtain copies of labels and evaluate formula for accuracy of critical raw material. Determine if label directions will yield the correct amount of additive in the finished food.
Evaluate food additive specifications and determine what tests are performed to assure that the finished product meets specifications. Check identity of raw materials including unlabeled raw materials.
Check controls to maintain product identity, i.e., prevent cross contamination and product mixups.
Finished Food Processors (Users)
Use of Banned Products
During surveys of plant storage areas and review of food product formulations, be alert for banned or illegal food additive products such as oil of sassafras, coumarin, 8-hydroxquinolone, thiourea, calamus, cyclamates, etc.
Document unauthorized use of an additive that is otherwise permissible, for example theuse of sodium nitrate to mask decomposition in fish or meat when it is permitted for use as a preservative.
Document the use of additives at levels above those provided for in the applicable food additive regulations. Any level above that stated in the regulation is deemed unsafe.
Conformance with GMP
In some instances no use level limitation is included in a specific food additive regulation. The use level requirement is to be in accordance with good manufacturing practices.
Good manufacturing practice for use of an additive may be defined as "the quantity of a substance added to a food that does not exceed the amount reasonably required to accomplish its intended physical, nutritional or other technical effect."
During surveys of plant storage areas take note of raw materials which refer to a food additive ingredient in non-specific terms such as antioxidant or emulsifier. The product is misbranded and may not be authorized for the food in which it is being used.
Evaluate food packaging materials (cans, cartons, paper, etc.) only to the extent necessary to uncover defects; i.e., malodors, abnormal appearing enamel linings, loose wax particles, absorption of lead from equipment, etc.
Evaluation of Additives Without Formulas
Observe the preparation of at least one product in which a restricted "GRAS" substance or a regulated food additive, including substances on extension, are used.
Calculate the amounts of additive in finished batch in ppm or percent by use of the Food Additives Nomographs (IOM Exhibit 530-B).
Obtain complete information on manufacturing and laboratory controls, including assays of the finished food, whenever the level is likely to exceed the tolerance. Where the firm has inadequate or no controls, inventory the amount of the regulated additive(s) used and compare it withthe volume of finished product for a specified period.
Collect Official Samples in instances where there is a clear-cut additive violation. No single sampling schedule is feasible for all additives and foods containing them. As a general rule, collect a representative sample of the same amount of finished food as would be required for a filth analysis.
Arrive prior to start-up to enable evaluation of the clean-up and start-up process, and to collect in-line samples of the first yeast through the dryer.
Note: A buildup of dust and moisture coupled with temperatures of 24° to 38°C (75° to 100°F) provides optimum conditions for growth of Salmonella.
Observe the following precautions:
Follow the firm's sanitation program for employees and wash and sanitize hands as necessary.
Refrain from any actions which could lead to criticism that you caused Salmonella contamination in the plant.
Wear clean coveralls and, if circumstances dictate, change them often, e.g. return from lunch, upon entering the dryer, etc.
Wear disposable head coverings throughout the inspection and use disposable plastic foot coverings in areas where floor contamination may be a factor. Heavy vinyl or rubber boots may be worn if they can be sanitized.
Always use aseptic technique, including hand sanitizing, when collecting in-line subs, raw materials, and finished products for Salmonella and other organisms.
Restrict unnecessary movement between various areas in the plant. When possible, complete your activities in one area before moving to the next area.
If management requires employees to shower and change clothes prior to enteringcertain areas, comply with the firm's policy. If disposable clothing is furnished employees for these areas, it may be used if available.
See IOM Subchapter 530 for general inspectional guidance, and attachment #1-Dried Yeast 'GMP' Guidelines. During dried yeast inspections, coverage will also include:
In general, follow non-fat dried milk sanitation guidelines and precautions. See the DEIO inspection guide 'Guide to Inspections of Dairy Product Manufacturers'.
Determine condition of the beer slurry storage tanks and check construction faults which would preclude or negate proper cleaning and sanitizing.
If firm uses sulfite liquor process, assess potential for contamination of starting liquor.
Observe the slurry hose inlet and determine how slurry is handled when unloaded from tank truck into holding tanks.
Determine how hose from truck to inlet is handled and whether it is properly washed and sanitized prior to use, and how it is protected from contamination between uses.
Determine what sanitizing methods and schedules are used on the hose and tank trucks; and opportunities for contamination.
Determine when storage tanks are emptied, cleaned, and sanitized; and evaluate the conditions.
If slurry passes through screens when pumped from tank trucks to storage tanks, evaluate method and schedule of cleaning and sanitizing screens and equipment. Examine the filter screen trough.
Determine what tests are conducted on all incoming raw materials to assure they meet company specifications and are free from Salmonella and other pathogens.
Equipment, Processing and Practices
Inspect and evaluate the condition of conveyors, elevators, flaker screens, funnels, drier drums, hoods, grinding mills, and filling equipment.
Examine equipment and premises for dust and moisture buildup.
Determine if machinery is properly constructed or covered so contents are protected from dust or contamination.
Examine roller drier drum for "wet ends" and how this condition is prevented or handled. "Wet ends" is yeast material that collects in rolls or lumps along the edges of the drier drum and is not properly dried. "Wet ends", may drop or be scraped off into the conveyor leading from drier to elevators.
The yeast powder from the flaker screens may be fed to the Fitz mill and into the filling operation through cloth sleeves. Examine the edge of the sleeves where they are attached to machinery for dust and static material.
Inspect and evaluate the air system throughout the plant. Investigate the source of air, location of intakes, environmental factors, type of filters, if any, and maintenance. If not disposable, evaluate schedule and method of cleanup and sanitizing.
Evaluate handling, cleaning sanitizing, and storage of brooms, scrapers, brushes, shovels, etc., used for cleanup or product handling.
Obtain formulation for yeast brewing including types of additives and vitamin enrichment.
If formalin is used as an equipment sanitizer determine if used properly.
Observe the storage facilities for adequacy and suitability in terms of sanitation and moisture.
Review tests performed on raw materials, finished products, and at points during processing, including vitamin assays of finished product.
Ascertain if any testing for Salmonella is performed on raw materials, water supply, air supply, finished products, or at critical points during processing.
Determine if drums of finished products are heat treated to kill Salmonella (terminal sterilization). If so, determine times/temperatures. Review recorder charts for terminal sterilization to ascertain if product was heat treated at the proper temperature.
Determine and evaluate firm's method of control sampling.
If firm uses formaldehyde as a preservative determine if finished product is tested and within permitted levels.
See IOM 454.2 - Routing of Samples for additional guidance besides what is furnished below. Use aseptic technique for all samples collected.
Collect in-line samples where inspectional conditions warrant.
Minimum sub size is 100 gm (4 oz). However, when collecting environmental subs (e.g., scraping, encrusted material, etc.) and collect whatever is available.
Include the first material through the dryer or dryers as one of your in-line subs.
Always bracket equipment.
Include 30100 gm (4 oz) subs of dried yeast produced on the day of the inspection and 30100 gm (4 oz) subs produced on a previous day. If the firm packages the yeast in retail size containers, collect these as your finished product subs.
Collect 30100 gm (4 oz) subs in duplicate, or 30 retail containers if packaged that way. Minimum sub size is 100 gm (4 oz).
If collection is made from bulk containers, use aseptic techniques and include open and closed controls.
If collected for labeling, take three retail units.
The areas/facilities used for the storage of FDA regulated products may present a significant opportunity for the contamination or adulteration of the products located there. Thecontrols employed by manufacturers may be negated by the careless or improper storage conditions or warehouse practices.
Coverage of general warehousing operations is intended to concentrate on the most vital and/or critical points of storage conditions that may adversely affect the integrity of the products stored in the facility.
These instructions are intended to address separate storage facilities as well as storage areas located at manufacturing sites. The same general approach applies.
Apply the following guidance to the inspection of all warehouse or storage facilities whether they are dedicated to foods, drugs, biologicals or a combination of these products.
At the beginning of the inspection, a survey of the outside of the facilities should be made to identify any evidence of rodent harborage, burrows, potential entries for pests and any other condition which would indicate possible sources of contamination of stored products.
A "walk through" of the facility should also be made to identify susceptible products; possible routes of adulteration with hazardous materials or pests; and storage areas for damaged/returned products, etc. Evidence of problems may be found near doors and windows, along walls, between and under pallets and other "out of the way" areas and near, on, or around susceptible products.
Check the salvage, distressed or returned merchandise area as a possible contributing source for contamination of nearby products. The reasons for the returns should be determined, as this area may contain evidence of other violative products. Types of evidence that may be available include: insect or rodent adulterated products, outdated products, misbranded products or label mixups.
Evaluate if storage temperature requirements are being followed. Examine refrigerators and freezers to assure they are functioning properly. Determine whether temperature recording devices (where required) are reliable and whether there are any alarm systems present.
Temperature control also includes provisions for maintaining the facility at an acceptable "room temperature" for the products in storage. Keep in mind the following:
1.Refrigerators should be maintained at or below 7.2oC (450F) and frozen foods should be maintained in a frozen state.
2.Temperature for products should be maintained at that determined by the nature of the product or as indicated on the label of the product. Be alert for evidence of temperature abused products such as thawing of frozen products.
3.Check the expeditious placement of incoming frozen or refrigerated products into appropriate storage and the shipment of such products to customers to assure proper handling.
Verify the adequacy of rotation practices. Determine how incoming materials are examined for signs of contamination or other violative conditions. Pay particular attention to such items as:
- Imported products and determine if the firm has noted any problems upon receipt of imports.
- Evidence of old products as indicated by dusty cases, leaking containers, etc.
- Outdated products
- Damaged products or containers
Determine if there is adequate separation between food and/or drug products and any hazardous or toxic materials.
Check if delivery vehicles are of sound construction and can maintain the shipped materials at required temperatures. In addition, check for any evidence of foreign, potentially toxic, material residues in the vehicles. The same applies to vehicles bringing in materials.
Documentation of Violations
Report the general distribution practices of the firm, review distribution records and examine shelf stock to identify suspicious shipments of products subject to abuse or which have been targeted for high priority investigation by the agency.
Document violative conditions and practices utilizing diagrams, photographs, exhibits and written descriptions. In addition, include examination of records to gather evidence for any potential follow-up. Cover such items as:
- Reasons for any returned products.
- Potential receipt or shipment of contaminated, adulterated, misbranded, etc., products.
Fully document the conditions and practices that have caused, or are likely to cause, contamination of the products stored on the premises.
Evidence should always be obtained which would facilitate further investigation of the problem and the potential removal of violative and/or dangerous products from the marketplace.
Information concerning suspect shipments should be supplied to your supervisor for follow-up and/or forwarded to the home district for review and follow-up investigation as appropriate.
Collect samples to document inspectional findings of insanitation, deterioration, cross contamination, etc., of products while held in the warehouse after shipment in interstate commerce. (Dealer violation - Section 301k of the FD&C Act).
Collect samples to document adulterated or misbranded products identified by observations of returned finished packaged products. Also, collect samples and document the shipment of such products from the inspected facility. These may represent violations by the manufacturer or supplier of the goods as well as the storage firm. (Section 301a of the FD&C Act).
DRUGS AND BIOLOGICS
The following guidance applies to the inspection of drug and/or biological warehouse or manufacturer's storage facilities for these types of products. The guidance is in addition to that expressed under the "General" part of this section.
Check if the storage areas are overcrowded. This could lead to mix-ups and/or cross contamination.
Verify if there are any practices which may result in products being stored under conditions of extreme temperatures. (Direct sunlight, near heaters, near outside walls, in unprotected areas)
Determine if the firm maintains a complaint or product defect file. Review to identify possible quality deterioration, label mixups, adverse reactions, etc., and report facts fully.
Verify if the firm checks on the authenticity of orders received, and determine the references that the firm uses. Have the firm demonstrate their procedure for checking potential customers on a large order on hand, or an unusual consignee.
Determine the firm's practices on redistributing returned products. When returned products are redistributed verify who makes the decision and what qualifications the person has.
Evaluate the system that is in place to recall drug/biological products. Determine the average minimum time required to notify all customers. Determine if any products are under recall, and if FDA is aware of the recall. Document any product recalls FDA is not aware of.
Determine what type of product, and how much, appears in the morgue area. Determine and document the reason for the returns to facilitate any follow-up. Follow-up any observations of:
- Particulate matter in liquids.
- Settling of solid material in suspension that cannot be resuspended after reasonable shaking.
- Color, shading changes or disintegration in tablets, etc.
MULTIPLE FOOD STORAGE
The following guidance applies to the inspection of multiple food warehouses or manufacturer's storage facilities. The guidance is in addition to that expressed under the "General" part of this section.
In addition to normal food warehouses, this guidance contains additional information on theinspection of salvage dealers. These are unique firms since they begin with contaminated or distressed materials.
Determine if a formal sanitation and pest control program is in place. Obtain the name and address of the professional exterminator, if used. Determine composition of rodenticide and pesticides in use, and if management is aware of products the exterminator uses.
Examine at least ten lots of products susceptible to direct rodent, insect or bird contamination such as: nuts, macaroni products, cereal, popcorn, beans, flour, dried fruit, poppy and sesame seeds, etc. Include imported products in these examinations.
Diagram the warehouse floor plan and grounds documenting where contaminated lots are stored and where insects, rodents, or other contaminants are observed.
Describe openings and structural defects which could permit rodent or other animal entry. Document these openings are actually being used.
Sample contaminated lots even if the lots will be destroyed voluntarily. Include as separate subs to the samples, any related insanitary evidence in close proximity to the lots.
When insect infested merchandise is found and the firm plans to voluntarily destroy the product, but not immediately, urge management to fumigate and denature the product to preclude use as human food. Also urge them to move the lot away from other insect susceptible foods. If management does not plan voluntary destruction and is requested to hold the lot, (check with your supervisor on this) urge that steps be taken to insure that possible infestation in the lot is not permitted to spread.
Conduct surveillance examinations of imported and domestic products for swollen cans, damaged merchandise and other conditions which render goods unfit for food. Inspect individual lots only when suspect goods are noted. See IOM Chart 2, for information on examination and sampling of damaged canned goods.
Many lots of food in a salvage warehouse would normally be actionable prior to being reconditioned. The critical question is the condition of products that are held for sale after they are reconditioned.
It is important to determine how the various products are reconditioned, and the conditions under which they are stored. Products awaiting reconditioning should be clearly separated from those which have been reconditioned and are awaiting sale to prevent recontamination, or the inadvertent sale of the unreconditioned lot(s).
Determine the source of the products the firm handles and/or has in stock. These could include:
- Disaster goods from floods, fires, wind or accidents (carrier).
- Bankrupt firms' stock
- Manufacturers' rejects
Examine at least ten lots of reconditioned products susceptible to direct contamination from rodents, birds or insects.
Conduct surveillance examinations of swollen cans (see IOM Chart 2), damaged merchandise and other factors which render goods unfit for food.
Determine how rejected materials are handled and what disposition is made of them.
Evaluate relabeling operations and determine the control and legality of labels. Also evaluate net weight and fill of container practices (see IOM 428.1).
If the firm has a retail outlet where salvaged food is sold to the general public, the foods sold must be fit for use and properly labeled.
Determine and report the basis for the firm's decision as to the safety of salvageable merchandise.
Determine how segregation of canned goods is conducted. Ascertain if the firm conducts a can-by-can examination of salvaged lots and what acceptance criteria is used. Canned goods, which should not be salvagedfor any reason because of potential health hazards, include:
- Springers, flippers, or swollen cans even though these defects may have been caused by denting.
- Leaking cans
- Cans with severe or sharp side seam or double seam (rim) dents, even though they are not leaking.
- Cans where the rim is cut through to the first layer of metal.
- Cans which are scorched from fire damage.
Determine if flood damaged cans are reconditioned according to current procedures.
When canned goods are salvaged due to mechanical damage, determine how side seam safety is evaluated and the qualifications of the person making the seam evaluation.
Examine salvaged canned goods that have been released for sale.
Examine canned goods in the firm's retail sale area for defects.
Inspect individual lots of canned goods only when an obviously violative lot is found.
IOM section 946.7 covers reconditioning hermetically sealed cans.
Determine what examinations are made of salvaged bottled goods.
Check the necks of bottles and under lip of cover for encrustation of filth or other debris (this is a critical point if the products were flood water damaged). IOM section 946.6 covers reconditioning of screw-top, crimp-cap and similar containers.
Check container codes. Code integrity must be maintained even if the labels are removed.
Bagged or Boxed Goods
Determine how bagged or boxed goods are examined and what criteria is used to determine what is salvaged and what is destroyed.
Evaluate handling of insect infested bagged or boxed goods. Determine fumigation practices and material used.
When a state or local inspector is participating in the inspection, assist to the extent necessary to assure corrective or regulatory action can be taken under state or local laws.
If there are violations of the FD&C Act, and the state or local agent is not able to assume responsibility for correction, fully document the violations and collect official samples of seizable size lots being held for sale.
When there is no state or local inspector present, inform your supervisor of the conditions at the firm. The District can seek assistance from the state or local agency having jurisdiction.
In addition to the inspectional guidance above, the following is detailed guidance for the collection of filth samples during warehouse inspections (this section, provided for the investigators convenience, is a copy of IOM sampling guidance, section 427, 427.1, 427.3 and 427.4).
Note: Any container from which a sample is removed must be properly reclosed to maintain its integrity.
Since adulteration samples are collected to confirm the presence of filth or other deleterious material, they are generally either larger or more selective than samples collected for economic or misbranding purposes.
When lots appear actionable, it is desirable to list recent sales from the lot in question. Follow up may be necessary as directed by your supervisor.
Provide a detailed description of observations, physical sub divisions which reflect the violative nature of the lot, and exhibits which corroborate your report of observations.
Record in your diary and subsequently in C/R Remarks, or on C/R Continuation Sheet (FDA 464a), or on Analyst Worksheet FDA 431, the results of your unit by unitexamination of the lot. Observations should be specific. Report the general storage conditions, the violative condition of the lot, the physical relationship of the violative lot to other lots in the area, how you conducted the examination and how many units you examined. Wherever possible, record quantitative observations.
Report the number and location of live and dead insects, pellets, or other adulteration discovered inside the containers as well as on their exterior surface. Provide graphic measurements of areas of urine/chemical stains on each container and the extent of penetration. Correlate findings of the unit by unit examination with any photographs and physical subdivisions collected.
Where the field examination is carefully described and documented, the sample collected from obviously violative lots may be reduced to carefully selected exhibits. The field examination and the report of findings will serve as the analysis. In this case prepare an FDA431, Analyst Worksheet. See IOM Exhibit 420-A.
In some situations, random sampling is unnecessary or even undesirable. Under these conditions you examine the lot and select the portions which will demonstrate the violative nature of the lot.
In addition to the selective samples being collected, exhibits should include diagrams and photographs to demonstrate the violative conditions reported, and which containers were sampled and photographed.
When collecting samples of products to show adulteration by filth be guided by the following minimum requirements for action against the merchandise. However, based on conditions observed, you may wish to collect samples as exhibits and evidence particularly where adulteration under section 402(a)(4) of the FD&C Act may be a factor, even though the criteria are not met.
- Rodent Contamination
- If you have evidence to show the warehouse is rodent infested and:
- Three or more of the bags in the lot are rodent gnawed; or
- At least five of the bags in the lot bear either rodent urine stains at least 1/4" in diameter, or two or more rodent pellets; or
- The food in at least one container in the lot contains rodent gnawed material, or rodent excreta or urine.
- Whether or not the warehouse is rodent infested;
- At least three bags bear rodent urine stains of at least 1/4" in diameter which penetrates to the product even though the product cannot be demonstrated to have been contaminated; or:
- At least two bags are rodent-gnawed and at least five bags bear either rodent urine stains at least 1/4" in diameter, with or without penetration to the product, or two or more rodent pellets; or:
- The food in at least one bag in the lot contains rodent-gnawed material or rodent excreta or rodent urine, and at least five bags bear either rodent stains at least 1/4" in diameter or two or more rodent pellets.
- Urine Stains - Examine suspected urine stains with ultra-violet light in as near total darkness as possible. A minimum of 15 minutes is normally required for the eyes to become properly adjusted to accurately differentiate between rodent stain fluorescence and normal fluorescence of rice and certain other commodities.
Submit for laboratory confirmation stained portions cut from the bag or container. Note: Small manicure scissors are excellent for removing the stained or gnawed portions of bags and transparent tape is excellent for picking up adhering pellets or small insects.
- When collecting exhibits of suspected urine stains, a control portion is required. As a general guide, collect the control from the opposite side of the bag or make the cutting large enough to separate the control area and the stain. Separate the controls from the stains and submit in separate containers.
- Handle the exhibits carefully and preferably with tweezers or gloves to:
- prevent loss of invisible evidence of rodent adulteration, i.e., hairs, adhering food particles and possibly rodent parasites.
- prevent chemical contamination of the stain or control areas through handling.
- prevent contracting the potential diseases or parasites associated with rodents, i.e., Salmonella (common on fecal material), Leptospirosis (urine), mites and fleas (nesting material or heavily traveled runs).
- If possible take stained cuttings from areas which have not been exposed for extended periods of time to light, in particular, ultraviolet light sources or to intense heat. If you have no alternative or cannot determine the stained areas' history, note the conditions on the CR.
- Certain chemicals in urine are photo-sensitive, therefore; maintain subs in a dark container.
- Wet, fresh or continually wetted runs may fluoresce poorly, but the odor of urine will usually be present and should be described on the CR. Fresh dry urine stains will fluoresce blue-white, while older stains may be more yellowish/white. Rodent hairs will look like blue/white streaks. Look for the typical droplet pattern because rodents commonly urinate while in motion. Report the presence of droplet patterns on your CR.
- Place cuttings and gnawed holes between 2 pieces of white paper, and then fold, roll, or leave flat and place into a glass container or other suitable container. This will hold the evidence in place and prevent possible loss of hairs or parasites due to static charges. Do not separate a multi-layer cutting. Avoid the use of polyethylene containers as insect fragments and rodent hairs may adhere to containers made from this material.
- Identify the top or external layer of a multi-layer cutting with a pencil. Exception: If there is a possibility that a multi-layer exhibit will separate through pre-analysis handling and shipment, identify all layers with a pencil. (Do not use ink as it often contains urea.) Handle exhibits carefully to prevent loss of microscopic evidence.
- Submit a minimal amount of product from under the stained area, preferably just the clumped product. This prevents dilution of thecontaminated product with uncontaminated product. Collect a product control from an uncontaminated area and submit as a separate sub.
- Note clearly on CR if the product or package contains or is directly associated with any of the following:
- Dried milk products (contain urea).
- Whole grain wheat (contains urea & allantoin).
- Animal feeds (urea is usually intentionally added).
- The following products may be difficult to evaluate because of either natural fluorescence or "quenching" of UV rays, even if contaminated. ("Quenching" refers to a covering up or a decrease in the ability of a product to fluoresce.)
FOODS NON-FOOD ITEMS High Gluten Flour (Natural)
Nut Meats (Natural)
Bean Flours (Natural)
Pop & Field Corn (Natural)
Spices (Natural or Quenching)
Gunny Sac (Quenching)
Bleached Sacks (Natural-White Glow)
Lubricants (Oils & Greases) (Natural-Blue/White to yellow/brown Glow)
Pitches & Tars (Natural-Yellow)
Detergents & Bleaches (Natural-White)
Sulfide Waste Matter (Natural-Blue/White)
Many types of bagging and threading materials will fluoresce under U.V. light, however, the characteristic rodent stain fluorescence can be identified by its yellowish color in contrast to the usual glow of chemical stains.
Note: Corn which fluoresces a "bright greenish-yellow" under blacklight examination is indicative of possible aflatoxin contamination. If normal cracked corn is blacklighted it fluoresces a bluish white color.See section g, below, for a blacklight screening procedure.
- Where you separate, count, or identify the various elements of an exhibit, (e.g.: sieve & find X number of rodent pellets), maintain the counted portions separate from the other subs. Note on the CR those subs that were counted, separated, etc.
- Protect the exhibits from being crushed.
- Urine stained areas may be photographed under ultra-violet light conditions. Check with your supervisor about the technical aspects of this procedure. Do not mark container surfaces to outline the stained areas when taking either ultra violet or normal photographs. This may contaminate the product by migration through the containers.
Each sample must consist of the following portions:
- A piece of unstained bagging, or portion of the container, which does not fluoresce, for a control.
- A number of pieces of stained bagging, or portion of the container, and any adhering pellets.
- A small portion of the product directly beneath the stained area. Do not dilute the contaminated product beneath the stain with the non-contaminated product.
- A portion of uncontaminated product from beneath the unstained bagging, or other container. This serves as a control, and should be collected in duplicate.
Submit each portion of bagging or container portion, pellets, material from beneath sampled area, control, etc., in separate vial or sub sample container.
- If you have evidence to show the warehouse is rodent infested and:
- Insect Contamination - Note: The criteria below involving dead insects only will not be used for action against any food if the food will undergo further processing which will effectively remove all the dead insects, e.g. processing of cocoa beans.
- The product contains:
- One live insect in each of two or more immediate containers; or, one dead insect in each of three or more immediate containers; or, three live or dead insects in one immediate container; plus
- Similar live or dead insect infestation present on, or in the immediate proximity of, the lot to show a 402(a)(4) violation.
- The product contains one or more live insects in each of three or more immediate containers.
- The product contains two or more dead whole insects in at least five of the immediate containers. Note: a situation such as this may follow fumigation of the lot and vacuuming of the exteriors of the bags.
- The product is in cloth or burlap bags and two or more live or dead insects are present on at least five of the containers. Note: Some live insects must be present. Product need not be shown to have become contaminated.
- The product contains:
- Fumigate exhibits as necessary being careful the fumigant does not destroy the exhibits or its container. If a fumigant is not available, freeze the sample. If fumigated, report in the Flag block of the CR and the FDA525 that the sample was fumigated and which fumigant was used.,
- Bird Contamination - If the product is in permeable containers (paper, cloth, burlap, etc.), and
- The product contains bird excreta in one or more containers, and you feel the insanitary storage conditions will clearly support a 402(a)(4) violation.
- Bird excreta is present on the exteriors of at least five of the containers, and the product contains bird excreta in one.
- At least 30% of the number of bags examined, but at least five bags, are contaminated with bird excreta; and at least three of the bags bear excreta stains which penetrate to the product, even though the product may not be contaminated.
Note: In all instances of bird excreta contamination the excreta must be confirmed by positive test for uric acid.
- General - Collect samples from lots suspected of dry chemical contamination in much the same manner as described above. After collecting a sample of the contents from immediately beneath the suspected area, collect residues from the surface of the bag or container. In the case of infiltration of loosely woven bags, shake or tumble the bag over alarge sheet of clean paper to collect the siftings as a sample.
When Selective Sampling consists of an actual sample of a product, however small, as distinguished from bag cuttings, rodent pellets, insects, etc., a 702(b) portion must be obtained. In such cases, collect duplicate subs of the product to provide the 702(b) portion. This 702(b) portion is usually not an exact duplicate of the product collected for the Selective Sample, but should be collected from the same bag, box, or other container of product sampled. Whether collected from a container or bulk, the 702(b) portion should be taken as close as possible to that portion selectively sampled for analysis. Specify for each sub and duplicate collected, the origin, manner in which taken, and the examination to be made.
- Blacklight Test Screening Procedure for Aflatoxins in Corn - Note: The USDA/FGIS has approved a number of commercial screening tests for detecting aflatoxin contaminated corn. However, these tests usually require a chemical extraction process and are therefore not amenable to FDA field examination procedures.
The blacklight test (also referred to as the bright greenish-yellow fluorescence test (BGYF)) is a presumptive test used to screen and identify corn lots that should be tested further for aflatoxins. The test is based on BGYF observed under long wave (366 nm) ultraviolet (UV) light produced by the molds Aspergillus parasiticus A. flavus on "living" corn (i.e. corn that has been stored less than 3 months). The growth of these fungi may result in aflatoxin production. Aflatoxins per se do not produce BGYF under long wave UV light. It is thought that the BGYF is produced by the reaction of kojic acid formed by the fungi and a peroxidase enzyme from living corn. Corn that has been in storage for a lengthy period of time (3 months or more) may give false positive BGYF. Therefore, determine how long the corn being sampled has been in storage and if it has been in storage over three months, Do not use the following field screening procedure.
Essential steps for this blacklight procedure are:
- A 10 lb. sample representative of the corn lot must be obtained by probing or by continuously sampling a grain stream.
- Examine using a 366 nm UV light (portable black-lights meet this criteria).
- Wear goggles or use a viewer that screens out UV light, shine the light on the corn sample which has been spread in a single layer on a flat surface in a darkened room.
- Use a 2 lb portion and carefully observe the entire corn surface one kernel at a time, examine the entire sample that was collected using this procedure.
- Count all BGYF glowers (kernels or particles that "glow" bright greenish-yellow). Compare the BGYF color with a fluorescent standard, if one is available. Remember normal corn, if it fluoresces, will fluoresce a bluish white.
- If four (4) or more BGYF particles are detected in the 10 lb screening sample, collect a sample for laboratory analysis.
In addition to information and instructions provided in Compliance Program 7304.005, Toxic Elements in Foods and Tableware and Cookware, and IOM Subchapter 530; review Compliance Policy Guide 7117.05, 7117.06, and 7117.07, and 21CFR 109.16 for guidance regarding cadmium and lead.
Ceramicware capable of retaining a liquid must meet the established guidelines for lead and cadmium. Ornamental and decorative ceramicware, intended for non-food service use, will not be required to meet the guidelines provided the ceramicware complies with 21CFR 109.16, (effective July 13, 1994).
Non-food service ceramicware must: a) not come in place settings, and, b) bear a conspicuous stick on label on a surface clearly visible to consumers (in letters at least 1/8 [0.125] inch or 3.2 mm high) that states one of the following messages.
- Not for Food Use. May Poison Food, or
- Not for Food Use. Glaze Contains Lead, or
- Food Use May Result in Lead Poisoning, or
- Not for Food Use - Food Consumed From This Vessel May be Harmful,
and either, mold or fire one of the above choices onto the exterior surfaces of the base; or for ceramicware that is not fired after decoration, permanently painted onto the exterior surface of the base or, a hole is bored through the potential food contact surface.
Optional Information provided on the ware includes:
- a statement concerning the decorative nature of the piece, such as: "DECORATIVE" or "FOR DECORATIVE PURPOSES ONLY." or,
- A visual symbol (see 21CFR 109.16) may be used and should be at least 1" in diameter. The symbol may be used on the temporary label or applied to the base piece described above.
Obtain the name, supplier and code of the glaze and decals used to produce each pattern or line of dinnerware intended for food use. Examine raw material invoices, labeling and production formulations for each glaze and/or decal to ascertain lead, cadmium, or other heavy metal content.
During glaze processing and application, determine the time/temperature of the kiln, time/temperature of cooling, and any other significant processing information. Evaluate the procedures for applying decals, paints, and other decorative material to food-contact surfaces. Obtain copies of guarantees or promotional literature making claims that products are non toxic, lead free, etc.
Evaluate the quality control program for each type of dinnerware product manufactured. Determine any testing of glazes,decals or other raw materials for lead or cadmium. If finished pieces are tested.
- Determine the types and numbers of pieces examined from each lot or pattern.
- Identify test methods for heavy metals and obtain copies.
- Evaluate laboratory equipment utilized in performing heavy metals assays.
- Review results of analysis for each pottery line.
- Obtain the name, address and qualifications of any contract laboratory used.
List interstate shipments of pitchers, bowls, mugs or cups and flatware with highly decorative surfaces intended for food use. Avoid flat pieces or complete sets.
During each factory inspection, conduct a field examination of the dinnerware using the Quick Color Test (QCT) and\or the Rapid Abrasion Test (RAT). The QCT and instructions for its' use and interpretation will be furnished by your district laboratory.
During each factory inspection, conduct field examinations of 2 lots of finished products intended for food use, using the QCT. Select the lots to be examined from highly colored or decorative products or from suspect lines. Each field examination will consist of six (6) units of identical size, color and design. Do not use damaged pieces. If field examination results are positive or suspect, arrange for the collection of an official sample.
For cups, mugs, and pitchers where the QCT result is negative, perform the RAT. Should the RAT result in a positive finding, collect 12 units (includes the 702b portion) of identical size, shape, color and design (refer to the current edition of CP 7304.005 for up-to-date instructions).
Samples may also be collected if violative level of cadmium are suspected. Cadmium ismost often found in ceramicware which contains red, orange or yellow colors.
If for some reason the QCT kit is not available during the factory inspection, collect 2 INV Samples of finished products intended for food use. Select the samples from highly colored or decorative products or from suspect lines.
Each INV Sample is to consist of six (6) units of identical size, shape, color and design. Do not collect damaged pieces for heavy metals analysis.
Official Samples (Includes 702b portion).
Collect official samples as a follow-up to violative field examinations or investigational samples. Official samples should consist of twelve (12) units of identical size, shape, color and design.
Flag your C/R "Ceramic Dinnerware." Pack individual units to prevent breakage during shipment. Determine the consignee's name, address and expected shipping date for each lot sampled and enter this information under the "Remarks" section of the C/R.
Sample houseware articles in the following priority order. If a known manufacturer or country has had problems with a particular type of item, sample that type of item first (refer to the appropriate attachment of CP 7304.005 for countries to emphasize during sample collection).
- Priority Order (Domestic and Import)
- Articles for holding liquid foods
Large hollowware: Capacity of 1.1 liter or more.
Small hollowware: Capacity of less than 1.1 liter.
- Flatware Distance between the rim and the internal depth of the plate does not exceed 25 mm.
- Plated Utensils
Metal-plated spoons, forks and knives, especially training utensils used by infants and young children.
- Articles for holding liquid foods
- Health Hazard Criteria (Domestic and Import).
Select samples from those posing the greatest health hazards. Some criteria to consider are listed below:
- Items having the highest surface area/volume ratio within each item identified above.
- Highly decorated and colored items.
- Items specifically intended for infants.
- Items routinely used to hold acidic liquids over a long period of time.
- Items used to prepare or serve hot foods (particularly those with colored interiors, including lids).
- Silver-plated items with soldered attachments, e.g., spouts.
- Items Not To Be Sampled
- Items specifically designed to contain dry foods (e.g., sugar bowls, salt and pepper shakers).
- Damaged pieces.
- Items solely intended for decorative purposes.
Wharf exams will be conducted using the QCT which will be furnished by your district laboratory. DO NOT routinely wharf examine more than one (1) line item per entry, unless the entry consists of items from different manufacturers, or you are able to identify different production codes from the same manufacturer. If multiple manufacturers and\ or production lots are represented in the lot, wharf examine up to one (1) line item per manufacturer and\or production code. If wharf examination results are positive or suspect, collect a sample for confirmation using pieces other than those wharf examined as the sample. For cups, mugs and pitchers where the QCT result is negative perform the RAT. Follow the instructions under Domestic Coverage-Field Exam.
Samples may also be collected if violative levels of cadmium are suspected. Cadmium is most often found in ceramicware which contains red, orange or yellow colors.
If the Quick Color Test (QAT) is not available, do the following:
Sample and examine 1 line item per entry, unless the entry consists of items from different manufacturers. In the latter case, up to 1 line item per manufacturer may be sampled and examined.
DO NOT sample more than 1 line item per manufacturer per entry.
Each line item sampled should be given a separate sample number.
Each sample is to consist of 6 units of identical size, shape, color and design.
Review Import Alerts to determine if lot in question is under automatic detention. If it is prepare a documentary sample.
Flag the C/R "Ceramic Dinnerware", and pack individual units for preventing breakage during shipment.
Establishment inspection for mycotoxin contamination requires careful evaluation of plant operations from the microbiological standpoint as well as the conventional general sanitation approach. High humidity and storage between 24o to 32.2oC (75o to 90oF) are most favorable to the growth of organisms responsible for aflatoxins. Direct particular attention to the control procedures regulating the incorporation of wet, moldy, insect damaged, and decomposed raw materials into the plant processing operation.
USDA provides FDA with copies of certificates of analysis on lots of raw peanuts with an aflatoxin content over 25 ppb. In addition, the National Advisory Council member companies will provide FDA personnelanalytical results on request. I/S shipment of lots with aflatoxin levels above 25 ppb is allowed when the consignee has adequate facilities to remove contaminated peanuts.
Inspect plant storage facilities to determine if they are clean, dry, well ventilated and free from conditions conducive to mold growth. Refrigerated or climate controlled storage is least susceptible to mycotoxin formation.
Evaluate sorting and inspection effectiveness to eliminate defective raw materials. Check for blending of sound stock with suspect material to dilute mycotoxin levels.
Assure that mycotoxin-suspect materials or by-products are not introduced into food channels. Mycotoxins are harmful to animals as well as humans.
Evaluate finished product processes which will reduce mycotoxins and/or microorganisms responsible for toxin production.
Evaluate analytical procedures, laboratory equipment, and qualifications of technical personnel.
Review inspection certificates and analytical reports from USDA, the Peanut Advisory Committee, State and other control laboratories.
Determine the disposition of lots containing over 20 ppb aflatoxin.
Mycotoxin contamination can occur in localized pockets of high concentration in particulate foods, such as grains, nuts, and copra. Commodities such as fruit juice and almond paste are more likely to be homogeneous.
Care must be exercised to insure that samples for mycotoxin analysis are as representative as possible. In sampling bulk food products, representative samples should be obtained through the use of trier or other device which will provide representative coresor portions from all sections of the container sampled.
Grains and oilseed meals intended for mixed dairy feeds: Mixtures are difficult to analyze and result in dilution of the contaminated ingredient. Individual ingredients should be sampled wherever possible. Grains and oilseed meals are most suspect. Corn, corn dockage, peanut meal, cottonseed meal, and coconut meal, should be sampled when available. Determine the quantitative formula or the proportions of ingredients used in the mixed feed.
Do not pack samples in plastic bags or other moisture proof containers as this may cause sweating and result in an unstable product.
Collect in-line samples to illustrate insanitary conditions capable of supporting toxin producing organisms. Give particular attention to contamination from insanitary equipment, wet and moldy raw materials, and decomposed static materials found in direct contact with food-stuffs during processing.
Collect representative samples of raw materials, in-process products, and finished products when in-plant observations indicate possible mycotoxin adulteration. Pickout material or "culls" should be sampled routinely to provide information on quality of raw materials and plant practices. When possible, sample on a 301(k) basis. Describe on the CR the inspectional observations which were the basis for collecting the sample.
See sample schedule chart attached as Attachment #2 for sample sizes for both domestic and imported products.
DRIED YEAST GUIDELINES~
These "GUIDELINES" set forth acceptable practices in the manufacture of dried yeast.
Buildings and Environment
The premises should be clean, orderly, well drained, and free of potential pollutants such as dust, wastes, vermin, and other pests.
Buildings should be so constructed, screened, and maintained to prevent entry and harboring of birds, insects, and vermin.
Building interiors should have smooth and tight ceilings, floors, and walls, permitting effective cleaning and sanitation.
All rooms should be of sufficient size for their intended purpose and have adequate lighting to facilitate sanitation.
Liquid processing, dryer processing and dry product packaging operations should be appropriately separated, preferably in separate rooms.
Service areas, such as boiler rooms, tool rooms lavatories, dressing rooms, etc., should be separated from the processing areas.
Traffic in and out of all plant areas should be controlled and restricted. No traffic should be permitted between the unpasteurized side and pasteurized side of the process.
Adequate and convenient facilities should be provided for personnel cleanliness, and the cleaning and sanitizing of equipment. Appropriate waste disposal, including properly trapped floor drains should be available.
The plant should have a regularly tested, potable water supply, both hot and cold.
The plant air intakes should be adequately filtered and so located and fitted to prevent entrance of contamination including dirt and dust, and so constructed to discourage bird roosting.
The dry air exhausts from processing equipment should be passed through distr collectors to prevent product dust buildup on the premises.
Air used in processing should be adequately filtered to prevent entrance of foreign material. and to maintain sanitary conditions.
Personnel Cleanliness and Practices
All plant personnel should be thoroughly instructed in plant sanitation guidelines, and the need for strict adherence to them. Key plant personnel should be trained as sanitary control officers to supervise sanitary practices.
Clean clothing, preferably white, and head covering should be put on after arriving at the plant, and worn in processing areas.
Only authorized personnel wearing suitable attire (as above) should be permitted in the processing area.
Persons with a communicable disease, or any other condition which could contaminate the product should be excluded from the entire plant.
Equipment and Utensils
Equipment should be easily accessible for cleaning and maintained in good repair and sanitary condition.
Effective cleaning methods, and schedules should be adopted.
All product surface contact equipment should be washed and sanitized prior to use, and after each use. It should be washed and sanitized dally when operating on an 8 hour basis, and weekly when on a 6 day continuous schedule (more often when practical).
Cleaning materials, and equipment (cleaners, disinfectants brushes, and other tools) should be properly identified stored, handled, and used in a manner to prevent contamination of the product.
The dry product handling system should be equipped with sanitary dust collection facilities. Dust collection units and filters should be changed as needed to prevent contamination of the premises and equipment.
Industrial vacuum cleaning units of sufficient capacity should be used for cleaning the plant interior, and the equipment, where applicable, daily. Separate units with attachments should be used exclusively for internal cleaning of equipment.
Indicating or recording thermometers should be used to check process and sterilization temperatures; temperature records of batches processed, and those which are sterilized should be maintained for 2 years after dlstributlon is completed.
Tank tucks and hoses, used for transferring beer slurry to storage tanks should be cleaned and sanitized after each load.
Storage tank inlet pipes should be appropriately capped, and hoses protected from contamination when not in use.
Pipes carrying raw materials to the yeast plant should be cleaned and sanitized regularly.
Raw materials should be Salmonellanegative.
Roller dryers and collectors should be located in a room separate from other operations to prevent airborne contamination. Buildup of static material on, and around the dryer should be prevented.
The moisture exhaust from the roller dryer should be arranged to prevent back flow of condensation. Drainage should be conducted away from the product.
Dryer stacks should be covered in a manner to prevent bird roosting, or other possible contamination.
The moisture exhaust hood should be cleaned and sanitized daily.
Blade and bladeholder should be cleaned regularly to prevent buildup of static material. Wet ends should be separated from product and discarded or reprocessed with sufficient heat to destroy any contamination.
Augers and other conveying equipment should be cleaned daily to prevent buildup of static material.
Sifter screens should be removed and cleaned daily.
Hammer and Fitz mill should be cleaned daily.
Floor sweepings and tailings should be collected and disposed of in a manner to preclude contamination of the finished product and plant facilities.
The product should be protected from moisture at all times.
New or adequately cleaned and sanitized containers should be used.
A minimum amount of containers, protected from airborne contamination should be on hand during the bagging operation. An hour's supply should be sufficient.
Bags liners, or other finished product containers should be filled in such a manner to preclude employee contact with the inner surfaces, dust contamination, or other practices conducive to product contamination.
Packaging room should be moisture proof and dry.
Packaging materials should be stored and handled to protect them from dust, moisture, and other contamination.
The finished product should be protected from moisture, vermin, and other contamination during handling and storage.
Sampling and Examination
An adequate* microbiological control program covering periodic examination of raw materials, inline sampling finished product, and plant environmental samples should be maintained to detect seeding of the plant or equipment with Salmonella.
* "Adequate" for this purpose cannot be clearly defined, and will depend on the total pattern of potential problems facing the firm, as well as the firm's history in regard to Salmonella contamination of its product. The investigator must consider such factors in coming to a conclusion on adequacy.
Finished product found to have a positive test for Salmonella should be adequately sterilized and shown Salmonella negative by adequate testing, or disposed of (for nonfood and nonfeed use), or destroyed.
Firms finding Salmonella in their finished product should immediately cease production, attempt to identify the source of contamination and take measures to eradicate it.
Environmental samples, e.g. air filter material, equipment dust, floor sweepings, sifter tailings, and vacuum cleaner dust, should be examined for Salmonella as often as is practical.
NOTE: Containers for samples of unprocessed, intact nuts, seeds, or grains must be sufficiently porus to provide for dissipation of moisture produced by respiration of the nut, seed, or grain.
Samples are to be collected from as many random sites in the lot as possible.
**Optional sampling program for seeds or dried fruit with a low incidence of contamination. Take initial 10 x 454 gm (1 lb) sample. If any aflatoxin is detected, resample 50 x 454 gm (1 lb) sample for determination of contamination level on which to base regulatory judgement.