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
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
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
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?
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
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?
Q.21. Does the ~leeway~ for inspection frequency described in IMS-a-23
include HTST tests?
Q.22. What about frequency for farm and plant water tests?
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?
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
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
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
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
Q.54. Is the watts 36a vacuum relief valve acceptable as a back
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
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
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?
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?
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
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.