M-I-85-7: Seminar Questions & Answers
200 ~C~ Street, S.W. Washington, D.C. 20204 M-I-85-7 June 14, 1985 To : All Regional Food and Drug Directors Attn: Regional Milk Specialist From : Milk Safety Branch, (HFF-346) Subject: Seminar Questions & Answers Enclosed are copies of the questions and answers which were discussed at the Region I & II Seminar held in June, 1994. Copies of this memorandum are enclosed for distribution to State milk sanitation regulatory agencies and State Milk Rating Officers in your Region. Robert L. Sanders ______________________________________________________________ Questions and Answers from Region I & II Seminar June 1984 Q. 1. What is the current status of yellow dye #5? A. The presence of yellow #5 must be declared on the label when used in any food. The Standards of Identity for milk and milk products, utilized by the PMO, only permits the addition of color when it is a part of characterizing flavoring ingredient, or in certain designated products, color additives that do not impart a color simulating that of milkfat or butterfat may be added to some cultured products. This would rule out the use of yellow #5 in Grade A milk and milk products. The standard and Identity for ~Eggnog~ however is currently under a ~stay~ and currently would permit color to be added. Q. 2. Are mozzarella and ricotta cheeses covered under the Food Drug and Cosmetic Act? A. Yes. However, the whey from these cheese manufacturing processes could come under IMS program if the whey is to be considered as Grade A. Q. 3.How does FDA view the presence of antibiotics in Grade A raw and finished milk products in relation to compliance with the Federal Food, Drug and Cosmetic (FD&C) Act? (Many states base enforcement of state laws, which also govern Grade A milk, on how the FDA handles enforcement of the FD&C Act.) A. Under the Federal Food Drug and Cosmetic Act, milk containing detectable antibiotics is adulterated and, as such, the adulterated product and individual (s) responsible for the adulteration are subject to the penalties specified in the FD&C Act. If and individual or company sells milk which has antibiotics in it to a milk hauler, milk plant, receiving station, another firm, or to the public; both buyer and seller have violated the law. (Provided that the milk, raw or pasteurized, is offered for sale and has either crossed state lines or is offered for sale across state line). The product may be seized, and the buyer, seller, and/or hauler may also be enjoined from further violations, and the buyer/seller/hauler may be prosecuted. However, there would normally be no action against either buyer or seller unless they knew about the antibiotics or had a history of dealing in antibiotic positive milk and may be using their lack of knowledge as an excuse. If they knew the raw milk was adulterated and offered the final product for sale, both might be guilty of a felony. If they knew the milk is adulterated and have effective controls to keep contaminated product from being offered for dale, they may legally attempt to recondition the product. When a product has been found to be adulterated and has been seized or under FDA injunction any process to reclaim the product must be submitted and reviewed by FDA on a case by case basis. We recommend that State handle this in a similar manner. Blending a product thought to be free of contamination with a product which is adulterated is absolutely forbidden. Product which has been blended in this manner is adulterated regardless of the finished product test results. Some firms presently under injunction for using antibiotic contaminated milk must follow the terms of the injunction even if they are more specific than the general conditions describe above. Q. 4.Is using a ten gallon can of unadulterated starter milk considered blending if the milk to be set is adulterated milk which is being reconditioned? A. Again blending cannot be used to produce a product which is less than the tolerance. If the addition of starter culture is a part of the submitted reclaiming process and the amount is such that blending is not a factor; it could be approved as part of the reclaiming process. Q. 5.May antibiotic positive dry milk products be disposed of by using a bio-digester that produces methane gas? A. Yes, if the product is denatured completely (so that it is no longer human or animal food), is probably labeled and is absolutely controlled (so that all product is accounted for). Note: In the one instance which was allowed by FDA in the Boston district, the agency also required that the resultant powder, sludge, or liquid from the digester be disposed of so that it could not be eaten by food producing animals. Q. 6.Can antibiotic positive dry milk or milk products be sold as animal feed? A. Not unless there are special circumstances. Q. 7.What type of circumstances? A. The contaminated dry milk or milk products may become a component of a medicated feed; provided the contaminated product is handled under a new animal drug application or a supplement to such an application. Q. 8. Do you know of any contaminated powder that is currently being handled in this way? A. No. Q. 9.What is the most sensitive method as described above which may be used by the Food and Drug Administration? A. Either the Bacillus stearothermophilus disk assay method or the Sarcina lutes method are appropriate for those products for which that test has been collaboratively studied and accepted. Q.10. How are unnatural inhibitors, other than members of the beta lactam group, handled under the PMO? A. The PMO requires ~No zone equal to or greater than 16 mm with the Bacillus stearothermophilus disk assay methods...~. It makes no distinction between beta lactam (Penicillin, ampicillin, cepharipirin or cloxacillin) and other products which will yield a 16 mm or greater zone size. Q.11. What about standard plate counts? A. M-I-83-2 specifies that standard plate counts for a sample which shows any zone size may be counted only if the zone is 12.8 to 15.9 mm and was caused by a member of the beta lactam group. All others shall be reported as ~Growth Inhibitor~ and the standard plate counts shall not be used for official purposes. Q.12. When dealing with violative samples other than antibiotics; Is a non violative sample needed before a temporary permit may be issued? A. No. In fact, a temporary permit is required before a sample can be taken. Q.13. Does the state central laboratory designate officially designated industry laboratories within a state? A. No. The responsibility for declaring an industry laboratory is the responsibility of the regulatory agency, State or local. They may act upon recommendations from the state central laboratory. If the officially designated laboratory is to be utilized for results of individual producer samples the laboratory must be certified by the State laboratory certifying agency. Q.14. How should a regulatory agency deal with an officially designated laboratory to insure timely sample results? A. As a condition of being officially designated the regulatory agency has a right to require that a laboratory agree to meet certain time frames. For example: telephone notice on the day violative samples are read, and written reports within a few days for all samples. (Note: This is separate from any monthly producer history update sheets, which a firm may elect to provide to the regulatory agency.) Q.15. How will slow sample results from officially designated laboratories be dealt with at ratings and check-ratings? A. Samples which are late enough to make regulatory actions difficult will be debit under Enforcement Rating, part I, Section II, ~Records systematically maintained and current.~ If the late sample causes regulatory deadlines to be missed or if they preclude regulatory actions, those sample results will also be debited under Item 10 of that same section. Q.16. What happens if a laboratory loses it~s official designation? A. If the producers do not have an official or officially designated laboratory at the time of a rating or check-rating, the rating or check-rating should not be made and the existing listing should be removed from the quarterly publication. If the rated supply had an acceptable laboratory at the time of the rating, but did not sometime during the rating period, then each producer~s record is evaluated using only samples run when the lab was acceptable. Appropriate sections of the enforcement and/or sanitation ratings are debited if there are less than four acceptable samples in the current or any previous six-month period. Q.17. Does a permit reinstatement have to be made when the farm tank is empty? A. Yes. Milk produced during a suspension was not Grade A and therefore may not be sold as a Grade A after a reinstatement. Q.18. If the suspension is made when the tank is empty and a reinspection shows that the needed corrections were made before the beginning of the next milking, may a temporary permit be issued without milk being lost? A. Legally and technically this is correct; However we do not believe it to be a good administrative practice. A producer who has violated the requirements of the ordinance after warning should be assessed a penalty. Even an overtime parker is assessed a fine. Q.19. Does the temperature of milk, taken four times during each six- month period from each farm have to reflect the temperature on the day an official sample was taken? A. It is desirable but not required. The choice of which days temperature readings are going to be taken, however, must be made by the regulatory agency. Q.20. May pesticide screening samples consist of commingled milk? A. Yes. Q.21. Does the ~leeway~ for inspection frequency described in IMS-a-23 include HTST tests? A. No. Q.22. What about frequency for farm and plant water tests? A. No. Q.23. Are milk plant and cooling water samples due semi-annually or every six months? A. The ordinance says semi-annually. This has been interpreted to mean that there cannot be any six-month period without the required sample. Q.24. Do plastic bags used to line ten gallon milk cans have to come from an approved single service source? A. Yes. If used as containers for Grade A products. Q.25. Are additional tests required for ultra pasteurized product (not aseptically processed product) over and above those tests required of similar HTST pasteurized product? A. No. Q.26. What is the minimum frequency of sampling for aseptic milk? A. There is none. Q.27. Do flavored products need to be tested four times each six months? A. No. The PMO requires that four samples each six months be collected and analyzed from each milk product defined, except aseptically precessed. The PMO has no separate definition for flavored milk. Flavored milk would be considered the same as milk. Bacteria and coliform sample results of flavored milk should be averaged with the results of unflavored milk taken on the same day. To continue the example, lowfat flavored milk is considered lowfat milk. Nonfat flavored milk is considered nonfat milk. Q.28. Are 1% milk and 2% milk required to be sampled separately? A. No. Lowfat milk is a single definition in the PMO. If 1% milk and 2% milk are both sampled on the same day the bacterial and coliform results would be averaged. Q.29. What about cream? There is a general definition fro cream and then several individual categories i.e. light cream, light whipping cream, heavy or whipping cream, whipped cream, and whipped light cream. A. The specific definitions apply. For example, if the plant produces light cream and whipping cream, both products must be tested four times each six months. Q.30. Where must the term Grade A appear on the label? A. The Pasteurization Milk Ordinance says that ~Grade A~ shall be conspicuous. The actual placement is up to states as long as the use of the term is not deceptive. The preferred location is the principal display panel. Q.31. May the words Grade A be inserted between words in the standardized name of a food? A. No, but it may immediately proceed or follow those words. Q.32. How is the use of the term ~Grade A~ regulated if milk is produced, processed, distributed and sold within a state? A. That is up to the State involved. Q.33. If consumer size whipped cream cans are not cleaned and sanitized and do not come from an approved single service source, what is marked? A. Item 12c if cans are not sanitized with at least 50 ppm chlorine (12.5 ppm iodine) or equivalent, and Item 11 if the plant cannot show that the lacquered surface meets PMO requirements. Q.34. Can any manufacturer of cans now be listed? A. They may but none are now listed. Q.35. Can quaternary ammonium be used to sanitize these cans? A. Yes, if used at 200 - 400 ppm, at pH levels of 5.0 or higher, at temperatures of 75xF or higher, and with a contact time of at least 30 seconds. The hardness of the water is also a factor and sequestering agents may be required. If the above conditions are not met, bacteriological data should be provided to establish the usefulness of quaternary ammonium under the modified conditions. Q.36. Is a CIP connection to a farm tank washing system in violation of item 16G (separation of CIP circuits from product) if the washing system is connected tot he spray ball at the top of the tank but is disconnected and open down at the pump near the outlet valve? A. This must be evaluated individually. If (by disconnecting the CIP connection from the top of the tank and turning on the washing system) you find that water or cleaning solution could have entered the tank, you have a violation. Also the uncapped CIP line may constitute a direct opening into the milk which could be contaminated by rodents or used by insects to enter the tank. Whether or not this is a significant violation depends upon several factors including the rodent or insect population in the milk house and the blockage (o lack of it) of the line to the tank by pump impellers or other impediments. Q.37. What is the difference between a mark under Item 13r (a), sanitized milk contact surfaces not exposed to contamination and Item 16r (d) product protection. A. Item 13r refers to protection of product contact surfaces which have been sanitized and which will later be in contact surfaces which have been sanitized and which will later be in contact with product. Item 16r is the place you mark unprotected milk. For example, an uncapped tank outlet valve is a violation of Item 13r (a) if there is milk in the tank. Item 16r (d) would be violated if one of the tank lids were open exposing the milk. Q.38. Please clarify what is meant by alternate means to protect water systems from high pressure pumps. M-a-57 provides for ~installation of any other device or means that will satisfactorily prevent a negative pressure on the water supply system.~ A. Any device which will prevent the line pressure from being reduced to zero is acceptable. Any device which will not operate until negative pressure is reached is unsatisfactory. Q.39. If the rating officer is unsure of whether or not a device will meet the above criteria, what authority should they use to find out? A. The state water authority engineer, using State or National plumbing codes may certify that any particular device will meet the criteria as described. If so, we will accept that certification. Q.40. What action is required when an enforcement rating is found to be more than ten points below the listed rating and below 80 at a check-rating? A. The FDA milk specialist is to recommend that the state make a new rating and allow 60 days for the state to take this action. Q.41. If a milk plant goes out of business, can its producers become a BTU without being re-rated? A. Yes, an amended 2359i using the old producer dates must be submitted. Q.42. If a dry milk plant also sells pasteurized milk or cream in bulk, are two 2350i~s required? A. Yes, one for the DMO related products and one for the PMO related products. Q.43. In order to call milk ~raw~ and still subject it to significant heat treatment, some dealers may be legally pasteurizing milk and then adding a small amount of raw milk back to it. Others are using ~almost~ legal pasteurization equipment to avoid having the equipment and milk tested. In all cases the product is labeled as ~raw~ or ~heat treated.~ We have already determined that the shipping plant or receiving stations have committed a violation, which is marked on the enforcement ration under labeling. How is this product evaluated at the receiving plant? What bacterial standards should be used and who is responsible to test the product? A. The product is not raw, pasteurized, or heat treated. No PMO bacterial or coliform standards can be applied. Therefore, it is not regulated by the PMO and cannot be considered to be a Grade A product. A plant which uses this product to make Grade A products, must be handled in the same manner as any plant which uses this product to make Grade A products, must be handled in the same manner as any plant which uses non Grade A dairy ingredients in Grade A products. Q.44. How is that? A. If such a practice is discovered at the time of a rating or check-rating, the rating or check-rating is not completed, and the firm should be immediately removed from the IMS list. Q.45. What about the newer warm milk separators which heat cream to 145xF during separation? A. These separators were designed to produce cream and skim milk or blends of cream and skim which is then legally pasteurized in an operation integral with the separation process. Q.46. Does this mean that products not defined specifically in the PMO, such as why cream, may not be Grade A? A. The high butterfat product separated from whey does not meet the Standard of Identity for cream. C.F.R. 21 Part 131.3 defines cream as ~the liquid milk product high in fat separated from milk~ the product is not separated from milk but rather from whey and therefore, even though it may have come from Grade A whey it cannot legally be called cream and used as a Grade A product or as an ingredient in a Grade A product. Except that it may be used as a part of the creaming mixture for Grade A cottage cheese. Q.47. May industry people be delegated to evaluate haulers under the sampling surveillance program? A. Certified industry milk inspectors may be so delegated. Q.48. May others? A. Only if the state has some means to control their activities. Some delegation or certification which can, for cause, be withdrawn. Such delegation or certification system should be reviewed by Milk Safety Branch and possibly the NCIMS prior to implementation. Q.49. How is it a partial debit calculated for a milk plant sanitation rating when one of several products violates bacteria, or coliform standards? A. It is based upon poundage, by product. See examples of this on page 22 of ~Methods of Making Sanitation Ratings of milk Supplies~. Q.50. What is required of an ultra pasteurizer which processes only milk products which were legally pasteurized after the addition of all ingredients? A. The thermometers must be accurate, the calculated holding time must be longer than two seconds for the product involved, and the charts must show that at least 280xF was achieved during product processing. Q.51. What if the above criteria are not met? Where do we mark it? A. Under Part 3 Item 4 on the Report of Enforcement Methods. ~All milk and milk products properly labeled.~ Q.52. Is a flow diversion device required? A. A flow diversion device is not required on the ultra pasteurized unit, provided that all product was previously pasteurized after the addition of all ingredients. Q.53. Can non-Grade A powdered milk be allowed to be used by an IMS plant to make ice cream or other non-Grade A products? A. Yes, Provided that it is processed in separate equipment or; processed after the Grade A products and all equipment is cleaned and sanitized subsequent to any processing of Grade A products. Q.54. Is the watts 36a vacuum relief valve acceptable as a back siphonage/backflow preventer? A. The company says no. We will consider them a violation of Item 8r on check ratings unless the State water authority certifies that these meet the PMO criteria despite the manufacturers denial. Q.55. The PMO tests for pressure differential switches, used to control booster pumps, describe procedures that cannot be used on the recently approved Anderson Instrument Co. Differential pressure switch. In particular, the manual moving and holding of indicator needles. (The Anderson is digital.) Neither the company literature nor operators manual specifies a test method. A method to accomplish this test was discussed with the Anderson Instrument Company engineer during our field trip. What is the method and may we use it? A. The method discussed was to follow the PMO test procedures Test 9 Part 4 Item (a) and (b) using the pneumatic testing device only and modifying (c) as follows: C - Remove the pasteurized side pressure sensor from the tee and return it to its proper position on the press. Cap the open end of the tee and return it to its proper position on the press. Cap the open end of the tee and the raw side pressure switch mounting opening on the press. With no pressure on the tee, start the HTST unit running with water. Heat the unit up until forward flow is achieved. The booster pump should be running. Gradually increase the pneumatic pressure on the tee. The rate of increase should not exceed 1 psi per 5 seconds at the set point q 5 psi. When the pressure on the aw milk sensor reaches no more that 1 psi less than that indicated for the pasteurized milk sensor, the booster pump should stop and the green indicator light on the pressure differential controller should go out and the red indicator light should be lit. Q.56. Finished product containers such as pasteurized cream cans are required to be tested using swab and/or rinse tested methods. Do pasteurized storage tanks need such testing? A. No. This portion of the pasteurized milk ordinance is not interpreted to include tanks. Q.57. What about ~totes~ or other large portable containers which are used as bulk yogurt or powder bins? A. No, only packages or actual product containers are covered. Q.58. Can a pressure relief valve mounted low on a HTST press between the regenerator and a glycol cooling section be acceptable? A. Each installation must be evaluated individually to ensure that adequate safeguards are being used. Each must be designed, installed and operated so that they cannot cause the pasteurized milk pressure in the regenerator to be less than one pound greater than the raw milk pressure at all times including startup, product run, shutdown and any emergency situation that might exist when a power or steam failure might occur when product is in the system. Q.59. Can raised wood floor calf stalls in a milking barn be debited under barn floors? A. If calf stall are not separated by tight partitions from the milking portion of the barn; they must comply with all aspects of a milking barn, including concrete or equally impervious floor materials. Q.60. Must silage carts in the milking barn be covered? A. Yes, if they contain feed. Feed stored in the milking portion of the barn shall be stored in such a manner as to not increase the dust content of the air, attract flies, or interfere with cleaning of the floor. Open feed dollars or carts may be used for distributing the feed, but not for storing the feed, in the milking barn. Q.61. Can you mark the cleanliness of the exterior of a pipeline when it is not in the milk room or stable? A. If the area that the pipeline passes thru on its way from the milking area to the milk room is a vestible; the vestible must comply with the requirements for the milk house and the exterior of the pipeline must be reasonably clean. If the area thru which it passes is not a part of the milking area, vestible, or milk house, and there are no openings or fittings in the pipeline, then cleanliness of the exterior is of no consequence. Q.62. Is the ~50 feet from the major sources of contamination~ for private water supplies an absolute, hard and fast rule? A. Some professional judgement is allowed for. Q.63. How can the milk solids and fat which are rinsed from milk storage tanks, pipelines and equipment be utilized? Can it be added to Grade A milk and milk products and how must these products be labeled? A. The PMO, Item 15p specifies that milk solids rinsed from equipment, containers, or pipelines shall be pasteurized only if such products are handled in a sanitary manner and maintained at a temperature of 45xF or less. The rinsings will undoubtedly contain some water along with solids not fat and butterfat. If sufficient milk solids not fat and butterfat are added to this watered product in the form of nonfat dry milk, condensed skim or whole milk and/or cream to bring the resulting products within the required limits; the resulting product would have to be considered reconstituted or recombined. The labels of the products would need to contain the words ~reconstituted~ or ~recombined~. The rinsings could be used as a component of any non standardized food or could be used as a component of ice cream or other frozen desert. The rinsings could be condensed and/or dried. Q.64. Do public water supplies have to be tested every three years? A. Not by the milk regulatory agency. Public water supplies are under the jurisdiction of EPA and are under a more stringent sampling and testing equipment. Q.65. If a water sample is bad, is it fair to debit the farm or plant during the time until a correction is accomplished? A. If a dairy farm or plant is using water from a supply which has been tested and found to exceed the limits for coliform bacteria it is a violation of the P.M.O. Q.66. Is a Watts 8a acceptable on a line to a CIP wash vat? A. The Watts 8a is acceptable in any application downstream from the last valve. Q.67. How will it effect a rating or check-rating if a field man does not know a rating is in progress and is working on the farms during the time a rating or check-rating is made? A. If the field man did not know about the rating or check- rating and is doing normal field work, there is no problem. If there is reason to believe that the farms are specifically being prepared for the rating, the milk sanitation rating officer or milk specialist is responsible for terminating the rating or check-rating. Q.68. May a state delegate have the right to suspend farms, for three of five bacteria counts, to non-certified industry people? A. No. Industry may exclude any producer any time they wish for any reason. If they exclude on three of five, they are, under PMO standards, voluntarily withholding the milk. This is not the same as an official regulatory permit action. Q.69. Would you review differences by region for protection devices for permanent and portable high pressure washers? A. There may be differences by state but non by region. M-a- 57 spells out how to protect high pressure water pumps. This memo makes no differentiation between portable pumps or permanent pumps, or whether or not the pump is hooked up. State water authorities differ as to what type of equipment meets the specifications and intent of M-a-57. We accept certification by state water authority that a particular arrangement or piece of equipment meets M-a-57 for dairy farms located in or regulated by the state. Q.70. May a low pressure cutout switch be located other than on a portable pump if the water and electrical connections are such that the pump can only be hooked up to receive water and power through the switch? A. Yes. Q.71. Do the tolerances for antibiotics supply to animal feed? A. Yes. The regulations regarding animal feeds and drugs are found in Parts 500-599 of Title 21 of the CFR~s. Q.72. Can powdered milk, which contains less than the specified tolerances of an antibiotic for which there is a specific tolerance, be fed to animals? A. Yes. Q.73. Why must a multi-tube precooler have one end terminate in a milk house for inspection, when releasers, milk hose connections, and ~stored in the barn~ inflations are all stored in the barn? A. If you follow the above logic to its final end, the bulk tank and wash vats could eventually be placed in the barn. As with any regulating document, a line must be drawn down somewhere. This is where we have drawn the line on this issue. Q.74. How should samplers carry and handle empty vials? A. They must be protected. Vials are usually received in plastic bags. It is adequate for the vials to remain in these bags, with the top of the bag folded down, and stored in a clean truck cab. If conditions are dusty, more protection is required. Q.75. May we empty vials in the ice chest? A. No. They collect condensation inside, which can affect the cryoscope readings. Q.76. What about the type of dipper in which the vial becomes the dipper and is adequately sanitized and rinsed in the milk prior to use? A. In this case, we have no objection to storing empty vials in the ice chest. Q.77. Will the next edition of ~Standard Methods~ contain methods to test whether vials are leak proof? A. Yes, but they will be listed as unproven methods for use by the regulatory agency for informational purposes. Q.78. How should microbiologically suitable (M.S.) water for laboratory testing be prepared? A. M.S. water may be prepared in the lab by deionization, reverse osmosis, or distillation or any other method acceptable by Standard Methods. Q.79. What is the status of the practice of making cheese from milk, which has been modified in an ultrafiltration or reverse osmosis unit? A. This is currently not permitted for cheese for which a Standard of Identity have been developed. See Questions and Answers from 1984 Region III Seminar for a further discussion of FDA~s concerns regarding U-F and R-O processes. Q.80. At what levels (high and low) should deviations in levels of Vitamin A and D trigger State action? A. It is up to each State. Some states have begun asking firms to voluntarily adjust vitamin levels when they are below 80% of the label claim or above 150% of the label claim at production, or above 120% of the label claim at sellby date. These are not hard and fast rules, but may be useful as guides. Vitamin A has been found to cause problems in children at 75,000 units per day for several days. Toxic effects on children for Vitamin D begin at about 40,000 units per day. The lack of these vitamins can cause vision problems, rickets, or poor calcium distribution, which also results in bone problems and poor tooth enamel development. Q.81. Milk with a zone size of 12.8 mm to 15.9 mm by the Bacillus stearothermophilus disk assay test for inhibitors is not actionable under the provisions of the PMO. Is product in this range actionable under the Federal Food, Drug and Cosmetic Act? A. Not at the present time. Q.82. In the case of bulk pasteurized product, is the regulatory agency for the shipper or the receiver responsible to test the product four time each six months? A. The regulatory agency for the shipping plant is responsible to test the product in accordance with PMO or DMO requirements. The regulatory agency for the receiving plant may test the product as often as they choose under Section II. Milk Safety Branch has developed an M-a- interpretation on the sampling of bulk shipped Pasteurized dairy products. It is currently being reviewed by NCIMS for concurrence at this time. Q.83. Under the new sodium labeling regulation, where do you place the statement about the relative amount of sodium, e.g., ~reduced sodium,~ ~reduced salt,~ etc? A. There is no requirement as to where such a claim may or must be placed. If it exists on the label, it triggers mandatory sodium labeling.