SECTION 10: ORANGE/OTHER JUICE
This guide is intended to be an aid in the inspection of orange juice processors. In addition to the information and instructions provided in IOM 530, prior to inspecting an orange juice manufacturing, processing or blending facility, the investigator should review the standards of identity for various orange juice products found in 21 CFR 146.135-146.154. The sanitation inspection of orange juice plants over the years has evolved to include an investigation for possible intentional adulteration. A good understanding of the differences in the orange juice standardized products described in 21 CFR 146.135 through 146.154 will be an aid in determining possible adulteration and/or misbranding.
Criminal investigations of juice adulterators have shown that as analytical capabilities have improved adulteration methods have become more sophisticated. While FDA criminal cases have focused on orange juice, it is possible for an unethical firm to gain a market advantage over honest competitors, and to defraud consumers, through the intentional adulteration of almost any juice or % juice drink. Therefore, when inspecting any fruit juice or % juice drink manufacturers, you should be alert for any evidence of economic fraud.
The primary market advantage to juice adulteration is the cost advantage the manufacturer can realize if he can extend the product or replace some or all of the juice ingredient(s) with ingredients of lesser value. There are many different variations on juice/% juice drink adulteration including:
- Dilution with water. In reconstituted juices, excessive simple dilution can be detected by a simple brix measurement (% by weight of soluble solids) which measures the percentage of fruit sugars in the product. The addition of water reduces the brix measurement. However, even the most sophisticated economic adulteration is ultimately designed with the addition of inexpensive water in mind. The extra steps taken by the sophisticated adulterator are designed to conceal the addition of water by making the water appear to be the water inherent in the fruit juice.
- Addition of sugar and water. Sugar is used to mimic the natural fruit sugar and to conceal the addition of water from a brix measurement. Any sugar ingredient can be used as a substitute for the juice sugars to defeat the brix test. A manufacturer making or blending juice concentrates may add only the sugar since the additional water will be added later when the product is reconstituted. Sweeteners from cane and corn are the least expensive sweeteners and offer the most economic advantage to a manufacturer. However, cane or corn sweeteners can be detected in orange or apple juice by using a carbon stable isotope analysis. Thus, the more expensive invert beet sugar has been more commonly used as analytical methods have become more sophisticated. Less sophisticated formulations for sugared juices may only involve sugar substitution for the juice ingredient(s) and the addition of extra water, while more sophisticated formulations will contain other adulterants in order to conceal the addition of the sugar. For instance, adulterated orange juice or grapefruit juice may have added amino acids to make the protein profile appear normal, citric acid to adjust the acid ratio, and/or trace minerals to make the chemical profile appear more normal. Adulterated apple juice may have added malic acid and/or trace minerals. Lemon juice may be adulterated with citric acid and may contain added sugar.
- Addition of pulpwash solids and water. Pulpwash is the residue exhaustively extracted by repeated water washing from the previously pressed orange (or grapefruit) pulp used to manufacture the fruit juice. Although it contains orange solids, it is an inferior product to concentrated pressed juice and it is not "a kind of orange juice". It is sold as a concentrate and is considerably less expensive than orange juice solids. Frozen concentrated orange juice (21 CFR 146.146) and products made from FCOJ may contain the in-line pulpwash from the same batch of oranges used to make the juice concentrate. However, addition of pulpwash under other circumstances is not permitted. Fresh juice and pasteurized juice cannot contain in-line pulpwash and the pulpwash obtained from their manufacture is sold separately for use in drink manufacture. The State of Florida requires all pulpwash manufactured in Florida to contain the marker, sodium benzoate, an ingredient not permitted in orange juice. Thus, the presence of sodium benzoate in an orange juice is suggestive of the addition of pulpwash.
- A less expensive juice like apple, pear, pineapple, or white grape or an inexpensive decharacterized juice (a fruit juice such as deflavored, decolored white grape or pineapple juice) may be substituted in part for a more expensive juice.
- One juice may be made to appear to be another juice which sells for a higher price. For example, an artificial color or another juice such as plum or pomegranate juice may be added to white grapefruit juice to make it appear to be pink/red grapefruit juice. An expensive grape juice (such a concord) might be extended with a cheaper, less desired grape juice (such as white grape) in order to obtain a higher market price.
- A preservative, especially one not approved for use in juices or drinks, may be added to extend the shelf life while saving plant clean-up, repair and maintenance costs. Orange juice may not contain added preservatives.
- A drink may declare added juice as a percentage of the ingredients, although it may not contain that percentage of juice, may not contain the specified juice, may contain a decharacterized juice, or it may not contain any juice ingredient.
- Pasteurized or reconstituted juice may be labeled as fresh squeezed juice.
- A conspiracy between firms to adulterate juice may be concealed through the use of code names for products or through the production of a "drink" ingredient at one plant/firm which is ultimately used for the production of a "juice" at another plant/firm.
Creative investigational techniques may be needed to detect juice adulteration. An investigator familiar with plumbing may be needed to trace the pipe and valve system. The building layout may need to be evaluated for secret tanks/rooms/pipes. Plant surveillance may be necessary to look for unusual delivery/ shipping patterns and/or for off-site storage/production facilities. It is not unusual for a plant which is adulterating juices to never be in production during an inspection. Thus, a lack production during your inspection may indicate an attempt to conceal certain illegal activities.
Under current law, food firms are not required to reveal formulations or show production records. Our criminal investigations have shown that illegal ingredients may well be added to juice even though the formulations given to FDA during inspections do not reveal their use. Thus, inspectional technique becomes critical to the detection of juice adulteration.
Look for the presence of likely adulterants in the plant, i.e. sugar, sugar syrups, invert syrups, pulpwash, decharacterized or other inexpensive juices, malic acid, or other acidulants. These materials may also be stored in tankers or other trucks on or near the premises. Frequently, a plant engaging in economic adulteration will manufacture a line of drink products which uses the likely adulterants so that their presence in the plant can be explained to an FDA investigator.
Probe the uses of any likely adulterants, any unlabeled/unidentified/coded products used, quantities purchased, quantities of "explanatory" product manufactured, frequency of manufacture, etc.
Be particularly alert to the presence of beet sugars and beet invert syrups as very suspicious. Manufacturers using a sweetener in a separate line of drink products can usually make a drink product of the same quality more cheaply with cane or corn sweeteners. The primary attraction of beet sugar and beet invert syrups is the difficulty of detecting it in finished juice products. Look for the presence of unexplained juice concentrates, i.e. white grape or pear juices, or pulpwash in the plant. Pulpwash is often identified by a name other than pulpwash such as "orange solids", "water extracted orange solids", "WESOS", etc.
If intentional adulteration or misbranding is discovered or if there is evidence suggesting intentional adulteration or misbranding, contact the Center for Food Safety and Applied Nutrition representative for economic adulteration (Stutsman 202-205-4681).
- Prepare a list of all raw materials and their suppliers.
- Make a list of all additives found and their suppliers. It may be helpful to inventory all additives and perform an audit of their use in "legal products."
- Determine what types of sugars are in stock and their uses.
- If orange pulp wash solids are in stock, determine their source and how they are used. 5. Try to determine if "off-site" storage facilities are owned or rented. These sites should be included in the inspection. A denial of the existence of such sites should be documented for possible future use.
- If pulp or other additives are used, identify the point at which they are added to the juice. Look for containers in the area which might suggest other additives. Look at incoming products and talk to the haulers.
- Obtain copies of pertinent production records covering products manufactured during the inspection and for all products sampled. These records may contain code names. Study them and try to determine irregularities. Get definitions for all terms. Elicit a statement from an appropriate person as to other ingredients used that are not listed and document the answer.
- Compare batch production records with the actual manufacturing operation. Watch the manufacturing operation to possibly identify irregularities. If adulteration is suspected, try to identify the person who is keeping the receiving, shipping, and production records and where those records are stored.
- If illegal use of pulp wash solids or other sugars is suspected, review any available records and attempt to determine whether the amount of juice solids received is consistent with the amount of juice solids produced. Document your findings.
- Collect Official Samples to document the receipt and use of any adulterants.
- IF equipment contains product or slime build up, report and take scrapings.
Collect samples as evidence of suspected orange juice adulteration following the procedure below.
Collect finished product samples, samples of all raw materials (including water) used to make the product, and samples of any suspected adulterants. Samples of finished product from several lots manufactured prior to the inspection should be collected as well as samples of product manufactured during the inspection.
- Each in-line sub of water, concentrate, orange pulp, or pulp washed solids will consist of 2-1 quart or 2-453 gm (1 lb.) subs as appropriate (includes the 702(b) portion). Subs of additives such as sweeteners, food or color additives or preservatives should be at least 100 gm (4 oz.).
- Each finished product lot sample should consist of 12-1 pint or larger subs or equivalent of the same code (includes the 702(b) portion).
SECTION 11: PRUNE JUICE
In addition to the information and instructions provided in IOM Subchapter 530 and 21 CFR 146.187, direct special attention to the following areas when inspecting these types of food establishments.
Examine 100 prunes as they enter the steep tank and examine for insect contamination, mold, or decomposition. Classify any as rejects if they meet the following criteria:
- Any piece showing insect tunneling, chewed pockets containing insect excreta, webbing or insects in whole or part, or webbing containing such adhering to any piece.
- Any piece showing a decayed area 12 mm (about 1/2 inch) or larger in diameter, or is appreciably sour or fermented.
When 5% or more reject prunes are noted during the above examination, next examine, in the same manner, the unsorted prunes being processed.
When over 5% reject prunes are noted, collect in-line samples to show the use of reject quality raw materials. Include subs of finished prune juice.
If a firm is reconstituting prune juice concentrate, collect from the filling line, two 1 quart subs of the reconstituted juice and two 1 quart samples of the concentrate being used. Submit to servicing laboratory for Standards analysis.
If an ingredient is being added which is not specified in the Standard, collect a sample (in duplicate) of the non-permitted ingredient.
Filth and Composition
Prune Juice - sample the square root of the lot, with a minimum of 48 and a maximum of 96 units.
Prune Concentrate - collect two 1 quart subs from each bulk unit sampled, with a minimum of 6 quarts and a maximum of 20 quarts.
Prunes - collect ten 1 lb (453 grams) subs in duplicate.
Check with the servicing lab if you wish to deviate from above sample sizes.
Report findings of the above examinations, if significant, on the FDA-483. Use the table format in attachment 5.
SECTION 12: TOMATO PRODUCTS
In addition to the information and instructions provided in IOM Subchapter 530, 21 CFR 113, and 21 CFR 155, direct special attention to the following areas when inspecting these types of food establishments.
When conducting a cannery inspection ascertain the pH of products produced. If pH is at or above 4.6 determine compliance with 21 CFR 113. Note: recently developed strains of tomatoes are tending to move some tomatoes from high acid to low acid.
Belt Examination and Evaluation
Immediately on entering the plant, randomly sample sorted tomatoes from the ends of processing belts. Collect at least 100 tomatoes for each examination. During the inspection take sufficient samples from each belt in operation to evaluate sorting practices.
List results for each sample examination using the rot classification method furnished on the FDA-433, Tomato Inspection Report (see Attachment 6). Smell "sour" tomatoes to confirm decomposition. Evaluate rot pickout percentages as follows:
The average accumulated rot point score in the example shown is 13+.
Enter rot classification on the FDA-433, but enter point score only after leaving the premises. Do not make the point evaluation available to plant management. Report on the FDA-483 the total percentage of tomatoes with rot for each examination, but do not include the point score.
Make at least two additional sample examinations at timed intervals on each belt when any examination results in a score in excess of ten points. In the examination of peeled tomatoes entering noncomminuted products (canned tomatoes, canned tomatoes with other vegetables) a score of five will be used as criteria for follow-up. Additional examinations beyond this are desirable to show a pattern of violation.
Examination of Field Containers
Sample field containers and other tomato lots awaiting processing and examine, evaluate, and report as for belt samples. A clearly violative condition correlates examinations of sorted tomatoes with similar or worse pickouts of unsorted tomato stocks. This must be differentiated from a single violative belt examination indicative of one small lot of unfit raw stock.
In violative situations, report the average holding time, storage conditions, and amount of static and incoming stock. Report the origin of tomatoes where long distance hauling with subsequent deterioration of stock is involved. Determine area growing conditions such as disease, insects, and weather, bearing on the availability of workable raw stock.
Examine incoming and recently received field stocks, especially broken and cracked tomatoes for fly eggs and maggots. Examine several lots to establish the relative level of field infestation.
In like manner, examine lots held for several hours or more, especially lots with significant drosophila infestation. Estimate the number of insects. Differentiate between house and vinegar flies in examinations of tomato stocks.
Report on FDA-433 and FDA-483 the number and percentage of tomatoes examined which show fly eggs and maggots.
Sorting, Trimming, Blending Practices
Check sorting and trimming equipment and practices in detail where violative belt examinations are encountered. If processing equipment contains product and slime build-up report, and take scrapings. Include the number of sorters, the length, width, and speed of the belt, the dumping rate, and the estimated load per foot of the belt, as well as the lighting conditions. Note particularly any sudden changes in belt flow, i.e., increase in the number of sorters, or unusual increase in tomato waste disposal, after you arrive. Additional belt examinations under these circumstances, are useful in showing that the firm can handle the operation properly.
Determine and report the disposition of tomato waste. Where comminuted products are prepared from skins and cores, and sorting and trimming is poor, raw material pickout data is important.
Borderline pickout results may be indicative of deliberate blending of good and bad lots on belts. Determine whether plant quality controls extend to supervising sorting and trimming operations or whether sole reliance is placed on mold counts. Observe the frequency of such counts in relation to raw stock quality.
Be alert for practices indicative of the possible blending of tomato products to reduce or obscure high mold counts. Finished stocks in segregated or "hold" status are particularly suspect. Examine the mold count results to determine the condition of such stocks. Attempt to determine the disposition or intended usage of any product which the control records show as questionable. Note blending can lead to an adulterated product.
Sorted and Peeled Stock
During rot examinations of sorted stock going into the chopper, also check for the presence of fly eggs and maggots in the cracks and broken areas of the tomatoes. Examination for fly eggs and maggots in sorted stock is more difficult than in the field hampers. Results normally reflect only minimal counts.
Where field examinations have revealed significant insect infestations and the stock is to be peeled, evaluate the peeling process for inadequacies in washing, scalding, and peeling. Note, particularly, whether cracked or broken tomatoes are trimmed.
Be alert for any stocks on plant premises bearing codes deviating from the firm's normal code system. These maybe violative products so identified for surreptitious disposition.
Review applicable parts of 21 CFR 155 to determine if a firm's products comply with the requirements of the Standards. Review the firm's Quality Control records to help determine compliance with the various Standards for tomato products.
Tomato products in 55 gallon drums or similar large containers, either aseptically filled or heat processed, should not be sampled while the shipment is enroute unless the owner accepts responsibility for the portion remaining in the opened containers. Arrange sampling of these products at the consignee (user) so the remaining portion can be immediately used or stored under refrigerated conditions. Use aseptic technique when sampling products in these types of containers.
Collect representative finished product samples where:
- Average accumulated point score of sorted tomato examinations, based on three or more pickouts, exceeds ten (in tomatoes for comminution) and rots are predominately fungal (anthracnose, alternaria, etc.).
- Average accumulated point score of sorted tomato examinations, based on three or more pickouts, exceeds ten (in tomatoes for comminution) and rots are predominately bacterial (sours).
- An average accumulated point score of five will be used as criteria for follow-up in the examination of peeled tomatoes with rot entering noncomminuted products (canned tomatoes, canned tomatoes with other vegetables).
Point scoring is primarily directed to the weighing of fungal rots (anthracnose, alternaria, etc.) in tomatoes. Bacterial rots (sours) are included in Class 4 (FDA-433), since their use in manufacturing reflects accompanying moldy tomatoes and poor sorting or improper control. Be sure to describe predominant rot types under "remarks" on the FDA-433. Where a violative point score is due primarily to inclusion of bacterial rots (sours), finished product mold counts may be within tolerance. Action may then be possible only on the basis of factory evidence against products made during the inspection.
To confirm rot type, collect samples of suspect bacterial rots for laboratory confirmation. Sample chopper juice or pulp to correlate with belt pickouts. Preserve samples in formaldehyde, 15 cc commercial formalin per pint of juice or pulp.
For exhibit purposes, submit representative rots obtained in belt pickout after sorting. Preserve these with 1% formaldehyde solution injected under the skin of the fruit, inject 3 ml in each of three locations. Place in a jar with a gel of 0.5% agar and 0.5% formaldehyde. Identify these investigational subdivisions as "exhibit".
Under "remarks" in the FDA-433, list any samples of materials in process, finished product, exhibits, and photographs taken to correspond with individual belt and field hamper examinations.
If the firm is suspected of adding water to the product, prepare a "Commercial Authentic Pack" as follows:
- Observe peeling of sufficient tomatoes to fill approximately thirty cans.
- Place peeled stock in clean filling vat and have firm's employees fill in the normal manner into thirty marked cans.
- Place cans on packing line for exhausting, capping and cooking.
- Collect the thirty pre-marked cans as a sample and collect an additional thirty cans of the same style product from previous days production or from stock packed prior to arriving at the plant.
- Submit both sets of subs for comparison against the "Commercial Authentic Pack".
Refer to IOM Sample Schedule Chart 2, for sample size.
If canned tomatoes are to be analyzed for peel, collect a minimum of 48 cans in duplicate.
If samples are to be analyzed for added water, collect an additional 12 cans in duplicate, for analysis.
If sample is to be analyzed for mold only, collect 12 cans in duplicate.
Bulk shipments (larger than No. 10)
If practical, collect aseptic subsamples of 2 pints, each aseptic subsample taken from the square root of the number of containers in the lot, with a minimum of 6 subsamples if possible. Fifteen (15) cc. of 37% solution of formaldehyde (commercial formalin) should be added to each 1 pint jar, and jars must be labeled to show the addition of formaldehyde. If permission to subsample cannot be obtained, take 1 can from each code or batch number. This includes the required 702(b) portion. See note above concerning large containers.
SECTION 13: PICKLES
In addition to the information and instructions provided in IOM Subchapter 530, direct special attention to the following areas when inspecting these types of food establishments. If the firm is producing acidified Fresh Pack Pickles, determine if the firm is complying with the requirements of 21 CFR 114, Acidified Foods.
Salt Stations and Salt Stock Tanks
Insects which breed in decomposed pickles or other decaying organic matter such as the lesser or little house fly, the latrine fly, the house fly, the rattailed maggot, and drosophila are of major sanitary significance. Examine 25% of the tanks for insect filth.
"Mill run" salt may be used but workers should not walk in the salt.
Tanks should be skimmed daily for debris and insects and the skimmings should be properly disposed of.
Newly salted stock ferments - scum growth should be removed regularly and disposed of so that insects are not attracted.
Examination of Raw Materials Used in Relish
Obtain the usual composition of relish in percent by weight of cucumbers as well as other ingredients to help appraise the filth load found in the sample.
Salt stock used for relish may consist of poor quality pickles, i.e., deformed, bloated, or blemished. However, in the absence of filth, grit, or partly/wholly rotted pickles, there is no objection to their use. Mushy pickles are caused by certain pectin splitting enzymes during fermentation. Soft pickles may be invaded by bacteria and fungi, but it is frequently difficult to determine if any mold or bacteria are present by field examination.
Examination of cucumber salt stock for relish - when whole pickles or large pieces are used, examine a representative sample of 100 units going to chopper.
Segregate and list objectionable pickles as follows:
For class 1 pickles, make a further determination of the surface area of the rot spots by size; up to 1 inch; from 1 inch to half of the pickle; and over half of the pickle. Take close-up color photographs of objectionable pickles. Collect exhibits of pickles showing typical rot and insect damage.
Laboratory examination of mushy pickles for mold is necessary to establish if they are objectionable. If over 5% of the units are mushy, cut a thin cross-section from each pickle. Place the slices in a quart jar with water and add 20 cc formaldehyde. Refer to IOM 427.6 for guidance on mold samples.
When small pieces of salt stock cucumbers, cauliflower, and peppers are used, rot determination by count is impractical. If rotten pieces are observed, collect a separate quart of each pickled vegetable. Preserve the samples with 20 cc formaldehyde. At the same time collect a sample totaling half a gallon of finished relish.
Check for insect larvae (maggots or larvae of pepper weevil) in fresh and salt stock peppers and figure percent of infestation on a representative sample. Examine any fresh pack peppers in which infested stock was used.
If peppers with rot are found, evaluate in the same fashion as for cucumbers.
Examine vinegar storage tanks for drosophila infestation and for vinegar eels.
Insect filth in sweet stock pickles - insects, particularly drosophila, are attracted to the sweetening tanks, and may be found in the finished sweet pickle products.
Sweet brine is frequently circulated within a tank and from one tank to another dispersing insects in the circulating brine. It is sometimes difficult to estimate the number of insects and parts in such circulating brine. Close examination of the inside tank walls may reveal drosophila above the brine level. These are the best indices of infestation in a tank.
When insects are found in a sweetening tank:
- Determine whether sweet brine in the tank is an intermediate or finishing brine and if it is circulated within the tank or between sweetening tanks.
- If the finishing brine is used as a packing medium, determine whether it is filtered prior to use and evaluate the filtration step.
- If sweet stock is held in infested tanks, determine anticipated date of packing.
- Evaluate tank covers used.
- List quantitatively, the extent of insect infestation by the collection of representative samples of filth from a definite area, e.g., square feet of the walls of the tank on the sweet stock and in a specified amount of brine from different areas of the tank if the infestation is widespread. If infestation seems to be isolated, collect specimens showing the types of insects.
Grit in pickles - excessive grit is frequently found in fresh pack pickles and in midget sweet pickles. Salt stock may occasionally contain excessive grit. If dirty cucumbers are packed, collect in-line and finished product samples.
Use of color and preservatives - green artificial color is sometimes used in relish without label declaration. Ascertain if the color is permitted for use and declared on the label.
Sorbic acid may be used in salt stock, to prevent yeast growth, and in finished pickle products, as a preservative. Where sorbic acid is present in the finished product, determine if it is declared on the label.
Examination of warehouse stocks - examine for evidence of spoilage, particularly in fresh pack pickles which may have been inadequately pasteurized.
If heavy insect infestation is found, examine 24 jars of the pickle product (other than relish) most likely to contain insects by inverting jars under strong light. Collect jars containing insects as a factory sample.
Bulk Salt Stock for Filth
If in barrels, collect a minimum of 12 half-gallon jars of salt with their brine; 2 from each of 6 previously unopened barrels to make 6 duplicate subs. Collect 1 sub from the top and the other sub from the bottom, if possible. If in tank cars, collect a minimum of twelve 1/2 gallon jars of salt stock and brine. If live flies are observed inside tank during sampling, note and estimate their number.
Finished Pickle Product - All Types
SUMMARY OF U.S. STANDARDS FOR QUALITY OF INDIVIDUAL SHELL EGGS
* If they are small (aggregating not more than 1/8 inch in diameter).
For eggs with dirty or broken shells, the standards of quality provide three additional qualities. These are:
- Dirty - Unbroken. May be dirty.
- Check - Checked or cracked but not leading.
- Leaker - Broken so contents are leaking.
Table 1: Pasteurization Method - HTST
Table 2: Pasteurization Method - Armour
Table 3: Pasteurization Method - Standard Brands
Table 4: Pasteurization Method - Ballas
COMMERCIAL EGG PASTEURIZATION PROCESSES
Table 5: Pasteurization Method - Spray Dried
|Liquid Egg Product||Minimum||Minimum Holding Time||Additives||Temperature||Temperature of Pasteurization (oF)|
|Egg white (albumen).||130||7 days||None.|
Table 6: Pasteurization Method - Pan Dried (Seymour Foods)
|Liquid Egg Product||Minimum||Minimum Holding Time||Additives||Temperature||Temperature of Pasteurization (oF)|
|Egg white solids.||125||5 days||6% moisture limit|
Note : this listing does not preclude the processing of egg products by methods of equal pasteurizing effectiveness meeting USDA and/or USPHS standards. Refer attachment 3- Egg Product Pasteurization Effectiveness, for minimum time, temperature, and pH conditions necessary to assure pasteurization.
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