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M-I-85-7: Seminar Questions & Answers


                             200 ~C~ Street, S.W.
                             Washington, D.C. 20204
                             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
                                        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
      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
     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
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
      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
           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
Q.17. Does a permit reinstatement have to be made when the farm tank is
      A.   Yes.  Milk produced during a suspension was not Grade A
           and therefore may not be sold as a Grade A after a
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
      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
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
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
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
      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
     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
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
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
     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
     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
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
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
      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
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
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.