HHS:PHS:FDA:CFSAN:OC:DCP:MSB
5100 Paint Branch Parkway
College Park, MD 20740-3835
M-I-03-13
October 3, 2003
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Questions and Answers from FY'02 Regional Milk Seminars, the Regional
Milk Specialist's Conference and Special Problems in Milk Protection Courses
Following are questions and answers from Regional Milk Seminars, held during FY
2002, the Regional Milk Specialist's Conference, held in June 2002 and the
Special Problems in Milk Protection Courses, held in August 2002.
In accordance with procedures established through the National Conference on
Interstate Milk Shipments (NCIMS), if an answer to these questions results in a
new understanding of a long-standing situation or installation, and the
condition as it exists does not present a public health hazard, reasonable
judgment should be exercised, and adequate time provided for modification and
correction.
Copies of this memorandum are enclosed for distribution to Regional Milk
Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation
Officers and State Milk Sanitation Rating Officers in your region. This
memorandum should be widely distributed to representatives of the dairy industry
and other interested parties and will also be available on the FDA Web site at
http://www.cfsan.fda.gov at a later date.
If you would like an electronic version of this document prior to it being
available on the CFSAN Web Site, please e-mail your request to
Robert.Hennes@cfsan.fda.gov.
/ss/ /ss/
Norris A. Robertson, Jr., CAPT Robert F. Hennes, RS, MPH, Chief
Milk Sanitation Officer Milk Safety Branch
Milk Safety Branch
QUESTIONS and ANSWERS
from the
CENTRAL (EAST) REGION MILK SEMINAR-10/16-18/2001,
SOUTHEAST REGION MILK SEMINAR-10/29-11/2001,
PACIFIC/SOUTHWEST REGION MILK SEMINAR-11/6-8/2001,
REGIONAL MILK SPECIALIST's CONFERENCE-6/4-6/2002
and the
FD 5107 SPECIAL PROBLEMS IN MILK PROTECTION COURSES-8/5-9 (Arlington, TX) and
8/26-30/2002 (Harrisburg, PA)
1. Grade "A" Pasteurized Milk Ordinance (PMO)-Section 1
Are eggnog flavored milk and milk products, i.e., low fat, reduced fat, or
non-fat, required to be pasteurized at 175°F for 25 seconds or 180°F for 15
seconds?
Whole milk, low fat, reduced fat or non-fat eggnog flavored milk and milk
products, containing less than one (1) percent egg yolk solids by weight of the
finished product, must be pasteurized at the minimum temperature(s) and time(s)
as follows:
150°F(63°C)-30 minutes
166°F(75°C)-15 seconds
These times and temperatures are consistent with those applied to other flavored
milk and milk products.
NOTE: Any eggnog product may also be pasteurized at the HHST times and
temperatures listed in the PMO.
2. PMO-Section 1 and Appendix L.
What Grade "A" milk and milk products can raw ultra-filtered (UF) milk be added
to as an ingredient? Can these products be labeled as Grade "A"?
Grade "A" raw UF milk is allowed to be added to yogurt, low fat yogurt, non-fat
yogurt and cottage cheese dressing, but not to dry curd cottage cheese. The raw
UF milk must be from a Grade "A" Interstate Milk Shippers (IMS) Listed source,
and the yogurts are Grade "A" products and must be labeled as Grade "A". If
cottage cheese is a Grade "A" product, under State law, it must be labeled as
Grade "A".
3. PMO-Sections 2 and 6; and Appendix G.
What are the requirements for pesticide sampling of raw and pasteurized milk?
Pesticide sampling and examination shall be conducted at the Regulatory Agency's
discretion. Either raw or pasteurized milk, or both, may be tested for
pesticides. The recommended sampling frequency is annually.
Appendix G., IV. -Detection of Pesticides in Milk states: "Any Regulatory Agency
that has adopted this Ordinance should operate under a control program that will
insure that milk supplies are free from pesticide contamination, in conformance
with Section 2
4. PMO-Sections 3 and 6
In most States, the producer samples, taken by permitted bulk milk
hauler/samplers, are used as the routine official regulatory samples for Section
6 testing of the PMO (bacteria, somatic cell, antibiotic and temperature). In
those States, these individuals often take the official samples from producers
that are in a "two of four" situation. Two of the last four samples exceeded
the Section 7 requirements of the PMO.
Occasionally, a sample will be taken from a producer that is in a "two of four"
situation before the producer has been issued the required warning notice or
before the required three day allowance for sample collection, provided in the
warning notice, for the producer to correct the violations has expired.
Are such samples official regulatory samples? What regulatory action should be
taken if these samples are also violative?
No. Producers shall be issued a warning notice and shall be provided at least
three days to correct the problem before permit action is taken based on three
of their last five official samples exceeding Section 7 requirements of the PMO.
NOTE: All samples taken by a permitted bulk milk hauler/sampler must be
considered official for animal drug residues, pesticides and other adulterants.
5. PMO-Sections 3 and 5; and Appendix B.
(a) Are bulk milk shipping containers (tanks), which are used to ship milk from
the main land to Alaska or Hawaii, commonly referred to as "floating barges" in
the West, subject to the same permit and inspection requirements as milk tank
trucks?
Yes. These shipping containers and the trucks that deliver these tanks to and
from the shipping docks are included within the PMO definition of "milk tank
trucks". Therefore, all the requirements cited in Appendix B., which apply to
the milk tank truck program, also apply to these shipping containers.
NOTE: These same requirements would apply, if these shipping containers (tanks)
were shipped by rail.
(b) If these shipping containers are owned by a 3rd party, which State should
issue the required Permit?
It can be whichever Regulatory Agency takes the authority to issue the permit.
The Regulatory Agency in the receiving State is responsible to see that the
shipping container has been inspected and permitted. If they do not have a
permit and a copy of the last inspection report available or an appropriate
regulatory sticker with the month and year of inspection identified, the
Regulatory Agency can conduct an inspection and issue a permit and charge a fee.
(c) Is the shipping container required to bear a permit?
Yes. Each milk tank truck shall bear a permit for the purpose of transporting
milk and milk products.
The PMO, Appendix B. states: "The permit identification and State issuing the
permit shall be displayed on the milk tank truck."
(d) Is an inspection report required to accompany the shipping container?
No. The PMO provides for two options: 1.) A copy of the current inspection
report shall accompany the milk tank truck at all times, or 2.) The tank shall
bear an affixed label, which identifies the Regulatory Agency with the month and
year of inspection. The affixed label shall be located near the tank outlet
valve.
6. PMO-Section 3 and Appendix B.
If an industry plant sampler (Appendix N.) is found NOT in substantial
compliance on their evaluation, what regulatory action, if any, is required to
be taken?
The sampling responsibility of this individual may be denied, depending on
Regulatory Agency discretion.
7. PMO-Sections 3 and 6; and Appendix E.
When issuing a temporary permit, following a Somatic Cell Count (SCC) permit
suspension, do you start out with a clean slate and ignore previous samples, or
do you go back, when the first sample is taken after the temporary permit was
issued, to determine compliance?
If the SCC sample, taken after the permit suspension, is below the SCC standard,
a temporary permit may be issued and the producer's record for SCC is wiped
clean. Therefore, sample results obtained prior to the permit suspension are
not used to determine compliance after a temporary permit is issued. A
temporary permit may be issued based on a satisfactory SCC sample, without an
inspection of the facility.
NOTE: Remember that all official regulatory Standard Plate Count (SPC) or
Temperature sample results, taken prior to the permit suspension for SCC, are
still in affect and must be considered with any official sample results received
after the issuance of the temporary permit.
8. PMO-Section 4
Please discuss the placement of the Term "Premium" on a Grade "A" milk or milk
product label?
The PMO states: "Descriptive labeling terms must not be used in conjunction with
the Grade "A" designation or name of the milk or milk product and must not be
false or misleading." The term, "premium" may be used on a product label in a
manner not associated with the product name or grade, i.e., made from "premium
chocolate", etc., if the statement is factual.
9. PMO-Section 5 and METHODS OF MAKING SANITATION RATINGS OF MILK SHIPPERS
(MMSR)
Why do dairy farm inspection reports have to be posted at the dairy, when they
are required to be kept on file at the Regulatory Agency's office?
The PMO requires that: "One copy of the inspection report shall be handed to the
operator, or other responsible person, or be posted in a conspicuous place on an
inside wall of the establishment. Said inspection report shall not be defaced
and shall be made available to the Regulatory Agency upon request." Also, Form
FDA 2359a-DAIRY FARM INSPECTION REPORT contains the following statement:
"Inspection of your farm showed violations existing in the items checked below.
You are further notified that this inspection sheet serves as notification of
the intent to suspend the permit if violations noted are not in compliance at
the time of the next inspection."
Inspection reports are posted so the permit holder can have it readily available
for reference. The rationale is that the operator or other responsible person
can periodically review the inspection sheet, identify what items need to be
corrected and make sure corrections are being made prior to the next inspection.
10. PMO-Section 5
(a) Who can conduct the certification of State Regulatory Officials that
certified Industry Personnel to conduct tanker inspections?
The PMO allows for the Regulatory Agency to certify Industry Personnel, with
their consent, to carry out cooperatively the provisions of the PMO with respect
to the supervision/inspection of milk tank trucks
A State Regulatory Official can certify Industry Personnel to conduct tanker
inspections. These State Regulatory Officials are not required to be certified
by FDA to perform this function.
(b) What are the recommendations for Industry Personnel certification?
Five joint comparison inspections with the State person(s) and they must be
within 80% agreement on all Items to obtain certification.
11. PMO-Sections 5 and 7, Item 8r; and MMSR
(a) What is considered to be adequate and reasonable action by the Regulatory
Agency when the individual water system on a dairy farm is in violation?
Regulatory action will depend on the type of violation(s) involved with the
water system. Significant water violations, i.e., direct contamination from a
polluted source, chemicals, etc.; major construction items that have the
potential to contaminate the water supply; and an imminent health hazard, etc.,
must be corrected without undue delay. The Regulatory Agency must act
immediately. If a significant violation does not constitute such a hazard, the
Regulatory Agency must grant the dairy farm at least three days to correct the
situation. Usually, minor water violations, i.e., 2-point debits from M-I-97-2,
should be corrected prior to the next routine regulatory inspection. An
unsatisfactory individual water supply sample requires re-sampling within 30
days. If they have not re-sampled within 30 days, Number 6 of Part I-Dairy
Farms on Form FDA 2359j-REPORT OF ENFORCEMENT METHODS would be debited for that
farm on a State Rating or FDA Check Rating
M-a-14 states: "That both the water supply and enforcement agency would be
debited when no initial water sample has been taken as required. If the last
water sample on file indicates contamination, the water supply must be
considered in violation and if no action has been taken by the enforcement
agency to correct the situation within a reasonable period of time, the
enforcement agency must also be debited."
(b) Where can I find the documentation for deducting points on water supply when
there are inadequate samples?
M-a-14 states: "Assuming the construction and location of a producer dairy
water supply is satisfactory, this office has been asked to advise whether such
supply and/or the enforcement agency would be debited during the course of a
milk sanitation survey when: (a) there is no record of an initial
bacteriological sample on file; or (b) the record of the last bacteriological
sample indicates contamination after a series of acceptable samples?
We believe that both the water supply and enforcement agency would be debited
when no initial water sample has been taken as required." (Refer to M-I-97-2--2
point debit) "If the last water sample on file indicates contamination, the
water supply must be considered in violation, and if no action has been taken by
the enforcement agency to correct the situation within a reasonable period of
time, the enforcement agency must also be debited." (Refer to M-I-97-2--5 point
debit)
12. PMO-Section 6
Is the requirement for annual vitamin assays for products that a plant chooses
to have vitamins added to fortify a product, which triggers a vitamin addition
claim, looked at once every calendar year or once every 12 month period? For
example, if one was collected on May 1, 2002, must another one be collected
prior to May 1, 2003?
The PMO indicates annually. Therefore, a sample must be collected and analyzed
in each calendar year to be in compliance with this requirement. The answer to
the second question is "No."
13. PMO-Section 6
If a plant adds vitamins to yogurt or sour cream in order to replace those
vitamins that are removed by reducing the milk fat level, is the plant required
to have annual vitamin assays on these products?
No. There currently are not any laboratory methodologies available for
analyzing yogurt and sour cream for vitamins?
14. PMO-Section 6
(a) Is it true that only those Grade "A" fluid milk products, which make claims
(such as "fortified" or "added") for vitamin A and/or D addition on the
principle display panel need be analyzed annually for vitamin A and/or D?
Yes.
(b) If a firm is also adding vitamin C to a Grade "A" milk or milk product, must
these products have annual vitamin assays for vitamin C conducted.
There currently are not any laboratory methodologies available for analyzing
Grade "A" milk and milk products for vitamin C.
15. PMO-Sections 6 and 11
(a) If an IMS Listed plant is receiving cold separated raw skim, low fat,
reduced fat milk and/or cream, is the State Regulatory Agency required to
collect four (4) samples in six (6) months of each cold separated product
received? If they are required to be sampled, what standards must it comply
with?
(b) Cold separated raw skim, low fat, reduced fat milk and/or cream is being
shipped from an IMS Listed plant, does the State Regulatory Agency sample each
cold separated product shipped, four (4) samples in six (6) months at the
shipping plant? If they are required to be sampled, what standards must it
comply with?
The answer to both of these questions is that samples of cold separated products
are not required to be collected under Section 6 of the PMO, with the one
exception, if this is the only raw milk supply for pasteurization that the plant
receives and utilizes. Then, this raw supply (cold separated product(s) is
considered their raw milk supply for pasteurization and must be sampled at the
required frequency of four (4) samples in six (6) months at the receiving plant.
16. PMO, Section 6 and Appendix B.
On large dairy farms, does the bulk tank sample need to represent the entire
milking herd?
No. A milk sample must be representative of the milk in the bulk tank, which is
being picked up by the bulk milk hauler/sampler.
17. PMO-Section 6 and Appendix B.; 3-A SANITARY STANDARDS and PRACTICES; and
M-a-93
(a) Who determines when agitation is adequate in large farm silo tanks?
The State Regulatory Agency must make such decisions, with input from the
Regional Milk Specialists. They should consult "3-A SANITARY STANDARDS" and
"STANDARD METHODS FOR THE EXAMINATION OF DAIRY PRODUCTS" (SMEDP).
3-A Standard 13-09: Farm milk cooling and holding tanks, which include vertical
tanks (silos), that were constructed to meet this 3-A standard and bear a 3-A
Symbol must be equipped with an information plate indicating the capacity of the
tank and whether the required agitation time is five (5) or ten (10) minutes,
based on the capacity of the tank. If the capacity is over 1,500 gallons (5700
L), the agitation time must be ten (10) minutes, or as required by the tank
manufacturer.
NOTE: For tanks, which have been modified, the agitation time indicated on the
information plate may not be appropriate.
3-A Standard 22-07: Silo-type storage tanks that are constructed to meet this
3-A standard are not required to have an information plate indicating the
required agitation time. This standard does not contain agitation time
requirements. Agitation time requirements for these types of tanks must be
individually determined so that the Regulatory Agency can verify and accept
samples collected from these silos.
Any silo tank equipped with automatic intermittent agitation must also have
their agitation time individually determined. In no case, shall the agitation
time be less than five (5) minutes.
Standard Methods: Chapter 3, 3.3(B) provides a method to determine appropriate
agitation procedures for bulk storage tanks and transportation tanks. This
method determines the agitation time by taking a series of milk fat samples at
specified intervals during agitation, until at least five milk fat tests
stabilize at a definite value. Adequate agitation is that degree of agitation,
by which a full tank will result in the milk fat content of the product in the
tank varying by not more than two standard deviations from the mean.
(b) What action should be taken when a farm milk tank proves to have
insufficient agitation?
If a tank or silo bears a 3-A Symbol as meeting Standard 13-09, and has not been
modified; however, it does not comply with the required 5 or 10 minute agitation
time, a 3-A challenge should be submitted. The integrity of the samples
collected from this silo are in question, and the bulk milk hauler/sampler
should be asked what information was used to determine proper agitation. It is
the responsibility of the bulk milk hauler/sampler to agitate the milk a
sufficient time to obtain a homogeneous product prior to sampling. They need to
follow the State and the manufacturer's guidelines. If acceptable samples
cannot be collected because of insufficient agitation, the ultimate
responsibility for the correction of this violation is the producer's. The
bottom line is for the Regulatory Agency to get the problem resolved so that
representative universal samples may be collected.
18. PMO-Section 6 and Appendix N.
For Appendix N., Producer Trace Back, and Section 6 Producer Testing, how many
times is an initial positive producer sample required to be tested in duplicate
with controls, keeping in mind that producer samples can only be tested by
certified analysts in a certified lab?
An initial positive producer sample will have a total of 5 tests run. The
initial test plus testing the initial sample in duplicate with positive and
negative controls.
19. PMO-Section 6 and the EVALUATION OF MILK LABORATORIES (EML)
Regulatory is submitting cooling water samples from several plants, which are so
opaque (rusty, black, green, etc.) that it is impossible for the lab to analyze
them by the colilert or the 10 tube fermentation method. LQAB tells the lab
that the Regulatory Agency must have the plants flush out their cooling systems;
however, the Regulatory Agency maintains that they do not have the Regulatory
Authority to do this. Is this true? If so, what can be done? The laboratory
feels it must reject these samples, as they cannot be analyzed properly. Why?
First, colilert is for use with source waters only. The Regulatory Agency
should have the authority to correct and handle this situation. The laboratory
must reject such samples; as such samples cannot be properly analyzed.
Laboratories will not take a sample that is not appropriate to analyze.
NOTE: A recirculated cooling water system without the required samples is in
violation of either Item 18r or 17p.
20. PMO-Section 7, Item 1r
When milking treated cows with the healthy herd, is it acceptable to employ a
"two (2) bucket" system and draw vacuum off the milk line? If not, how about
using three (3) or four (4) buckets?
No. It has never been acceptable to connect the treated cow milking equipment
into the milk line while milking healthy animals. This practice has resulted in
documented cases of antibiotic residues in milk.
21. PMO-Section 7, Item 2r
Please discuss the use of "Cow Mats" placed on the floor in the milking areas of
milking facilities?
The use of floor mats on cow standing surfaces in the milking area is acceptable
only under the following conditions:
1. They are relatively smooth, impervious, easily cleanable and in good repair.
2. They are maintained in a clean condition and are not fastened permanently to
the floor.
3. They are installed so they may be easily lifted, inspected and cleaned
underneath.
4. They may not be in one long continuous section, which makes them impossible
to maintain and inspect.
5. When cracked, worn, or frayed, they must be replaced or removed.
6. If the producer is not able to properly maintain or clean them, the
Regulatory Agency shall take action to have them removed.
22. PMO-Section 7, Item 5r and Appendix H.
For direct loaded tankers on the farm, which are used for the cooling and
storage of milk on the farm, the PMO requires that the connection to the milk
tank truck must be made from inside the milkhouse and the milk hose connection
must be completely protected from the outside environment at all times. May
this be accomplished by providing a lean-to roof extension, added onto the
milkhouse, and/or just a cabinet that houses the valve assembly on the milk tank
truck?
No. This would not provide the required protection cited in Item 5r.
23. PMO-Section 7, Item 5r
(a) Can a digital readout that is a part of the temperature recording device be
used to satisfy the indicating thermometer requirement when transportation tanks
are used for the cooling and storage of milk on a dairy farm as required in Item
5r?
Yes.
(b) Can this be a single probe-sensing element or must it be a multiple
probe-sensing element?
If it meets the applicable requirements of Appendix H. and Item 5r of the PMO
and is acceptable to the Regulatory Agency, it can be a single probe-sensing
element.
24. PMO-Section 7, Item 5r
Item 5r requires that the indicating and temperature recording device, required
for direct loaded tankers used for the cooling and/or storage of milk on dairy
farms, must be compared during a routine inspection and the results recorded on
the recording chart. Is milk required to be in the line for this comparison,
thus requiring a milking time inspection?
No. Regulatory Agency personnel are required to conduct this comparison and
record the results on the recording chart during every routine inspection
conducted either at milking or non-milking times.
25. PMO-Section 7, Item 5r
In a "direct loading" situation where is the acceptable place to collect the
official sample?
At a location acceptable to the Regulatory Agency.
26. PMO-Section 7, Item 8r
May non-potable water be used to clean a milking parlor?
Yes. However, it can only be used for non-product contact surfaces in the
milking parlor, i.e., floors and walls; provided, it is used in a manner as not
to contaminate milking lines, claws, receivers, or other milk contact surfaces
or create a cleanliness problem in the milking parlor.
27. PMO-Section 7, Item 8r
Are portable "high pressure" washers subject to a debit on ratings and
check-ratings?
Yes. If they are not protected in accordance with M-a-57, this would constitute
a 2 point debit under Item 8r.
28. PMO-Section 7, Item 8r
Are 288-A anti-siphoning devices acceptable for use in continuous pressure
situations?
No.
29. PMO-Section 7, Item 8r and Appendix D.
Can H2O2 be used as a disinfectant for farm water supplies?
No. H2O2 has not been accepted by the Environmental Protection Agency (EPA) as
a disinfectant for farm water supplies.
30. PMO-Section 7, Item 8r and Appendix D.
(a) What protection is required for a plate cooler, which utilizes a potable,
non re-circulating water supply to cool the raw milk on a Grade, A dairy farm?
The question deals with the system described as follows: The main potable water
line supplies water to the milking facility. Separate distribution lines supply
potable water from the main line to the raw milk plate heat exchanger and the
water-cooled air compressor. The discharge line from the air compressor is
connected with the water discharge line from the heat exchanger downstream from
the outlet from the heat exchanger but before reaching the reclaimed water tank.
There are no other connections.
One way of achieving the required protection for the potable water supply would
be to either install an acceptable back-flow prevention device or provide an
acceptable air-gap at some point between the heat exchanger water discharge
outlet and the nearest non-potable water source located downstream of the heat
exchanger.
(b) Are we going to require backflow devices on plate coolers at dairy farms,
to include those with a bypass line?
No. However, if a potable water line was tied into the plate cooler water line
after it exits from the plate cooler then adequate protection on the potable
water line would be required. Currently, there is not a requirement that the
potable water line be protected before it enters the milk plate cooler. We have
considered water exiting a plate cooler, heat exchanger, or compressor on farms
as not being potable. EPA has stated that it cannot go back into the well;
therefore, if there is any cross-connection with any potable water lines
downstream from the plate cooler, the potable water line(s) must be protected
from contamination
(c) May water that has passed through a plate cooler and compressor be reclaimed
for use in the milkhouse and milking operation?
Yes. It must meet all the requirements cited in Appendix D., Part VI, Water
Reclaimed from Heat Exchanger Processes, to be used in the milkhouse and milking
operations. One exception is for reclaimed water covered under Proposal 154
from the 2003 NCIMS Conference which states: "NOTE: Water from the current
milking, obtained directly from the discharge of a raw milk heat exchanger, may
be utilized for the one (1) time, pre-rinsing of dairy equipment or for
non-potable uses. This heat exchange water may be used if:
1. The water is used for the one (1) time pre-rinsing of dairy equipment
including, milk lines, milking claw assembly, milk receiver, etc., and
discharged to waste.
2. The water is collected directly from the plate heat exchanger into the wash
vat or utensil sink.
3. The water piping system shall meet the requirements of Item 8r of this
Ordinance."
NOTE: Water which has passed through a plate cooler or compressor may not be
directly connected to the potable water supply system without an appropriate
backflow prevention device being installed on the potable water supply line
located prior to the connection to protect the potable water supply. Also,
downstream from this connection there cannot be any other connections to the
potable water supply system without appropriate protection being applied to each
potable water supply line.
31. PMO-Section 7, Item 9r; and M-I-00-8
In the course of a FDA check rating, will rolled ferrule pipe couplings
automatically be debited as a PMO equipment violation?
No. They should be debited only if those fittings fail to meet the sanitary
construction criteria for milk product contact surfaces; however, these type
fittings should be evaluated thoroughly since they tend to have openings,
crevices, etc., at the joint between the pipe and the fitting.
NOTE: 3-A Accepted Practices for the Design, Fabrication, and Installation of
Milking and Milk Handling Equipment, Number 606-05 and 3-A Sanitary Standards
for Sanitary Fittings, Number 63-03 allows for these to be installed on dairy
farms when existing systems are modified or repaired on site; if the fittings
are installed with no cracks; and if they meet other applicable product contact
surface requirements in 606-05.
**NOTE: This information regarding the 3-A status of rolled on fittings
supercedes and replaces the information in Question 13 form M-I-00-8.
32. PMO-Section 7, Item 10r
What federal agency regulates anti-microbial cleaners?
The EPA registers these chemicals as a fungicide.
33. PMO-Section 7, Items 10r and 11r
Is it appropriate to debit both cleaning and sanitization when a cleaning line
(mechanical or CIP) is found soiled on a dairy farm?
Yes.
34. PMO-Section 7, Item 12r
Explain the changes in Item 12r, page 35 of the 2001 PMO, which deal with the
separation between the milking and housing areas.
Item 12r, Administrative Procedure #2 states: "The milking barn or parlor must
be used only for milking. Concentrates may be fed in the barn during milking
but the barn shall not be used for the housing of animals. When manual cleaning
of product contact surfaces is necessary, the cleaning shall be done in the
milkhouse. Provided, in the case of a milking parlor that opens directly into
an enclosed housing area, through a covered holding area, the holding area may
be seasonally enclosed when:
a. There are no manure pit openings in the parlor, holding area or in the
housing area close enough to affect the milking parlor.
b. The cattle holding and housing areas are maintained in good repair and
reasonably clean.
c. With respect to dust, odors, rodents and insects, the entire area meets
milking parlor standards and the parlor is free of evidence of birds.
In addition, construction and cleanliness items identified above shall be
evaluated in the appropriate Ordinance Sections."
Generally, if milking equipment is being cleaned and stored in the milking area,
it is required to maintain a complete separation between the milking area and
cattle housing area. However, with this new language, on a seasonal basis only,
the milking parlor may be directly connected to the cattle housing area through
a completely enclosed holding area if all of the requirements listed above are
met and are being maintained.
35. PMO-Section 7, Item 13r
During farm inspections, when it is not a milking time inspection, what exactly
is evaluated under Item 13r?
If you observe that a significant number of the milking herd animals are soiled,
with caked manure, mud, etc., which in all likelihood was present on the dairy
animals when the herd was last milked, it would be considered a violation of
Item 13r. Professional judgment should be used when determining this violation
during non-milking times.
36. PMO-Section 7, Item 14r and Appendix B.
Tankers that do not have a pump or milk hose often pick up milk at the farm
using the farm's unloading pump and hose. May the connection to the tanker be
made outside the milkhouse, and if unacceptable, where is this item debited on
the inspection form?
Yes. However, if it is not being conducted in a sanitary manner to protect the
tanker valve and the unloading hose, it would be debited under Item 14r, and if
observed while evaluating the sampling procedures of a permitted bulk milk
hauler/sampler, it would be debited under Item II. Hauler Sanitation Procedures,
Sub-item 1 of Form FDA 2399a - MILK TANK TRUCK, HAULER REPORT AND SAMPLER
EVALUATION FORM.
37. PMO-Section 7, Item 15r
(a) Can a veterinarian take over-the-counter (OTC) tetracycline and repackage it
in packets for footbaths?
Yes. M-I-92-10 (addendum) in the Section on footbaths states: "The use of
antibiotics for footbaths/sprays constitutes extra-label use. Veterinarians
should comply with the labeling requirements for extra-label use of drugs under
Item 15r of the PMO."
This product, if found on the farm, must be properly extra-labeled by a
veterinarian to comply with the PMO.
(b) May a layperson buy over-the-counter tetracycline and repackage it in
packets for footbaths?
No. The issue here is a layperson re-packing and using an OTC drug for
extra-label use. Extra-label use is only allowed for veterinarians and then
under specific regulations.
If this is a large-scale problem or the person does not stop once they are told
what they are doing is not legal, the State should contact their Regional Milk
Specialist, who should contact the FDA District Office and request an
investigation.
38. PMO-Section 7, Item 15r
What are the labeling requirements for cases of Oxytocin?
The manufacturer must properly label each bottle of Oxytocin, within the case.
If there is evidence that Oxytocin is being misused, i.e., used for increasing
milk production, this should be reported to your Regional Milk Specialist, who
will notify FDA's Center for Veterinary Medicine (CVM), Division of Compliance,
Case Guidance Branch, HFV•236.
39. PMO-Section 7, Item 15r
Is Bayticol Pour-On approved for use in the United States?
No.
40. PMO-Section 7, Item 15r
Is ECP, Estradiol Cypionate, exempt from the PMO labeling and storage
requirements?
No. ECP, Estradiol Cypionate, is an Estrogen compound marketed by UpJohn for
use in cattle, including dairy cattle. ECP is an injectable prescription drug
by its labeling. It is not a Biologic, a Prostaglandin, or a Pituitary Hormone;
so it is not exempt from PMO labeling and storage requirements on routine
Regulatory inspections, State Ratings or Federal Check Ratings. There is no
milk discard time on the label much like a number of drugs that we consider okay
for use in dairy cattle. The assumption is zero (0) milk discard time, if used
according to it's labeling. If used according to the label and since it is an
Rx drug, it would require the veterinarian's name and address to comply with the
PMO and avoid a debit.
41. PMO-Section 7, Item 15r
(a) Are they required to label each individual intra-mammary infusion tube (144
count of Rx drugs labeled for dairy cattle) with the name and address of the
prescribing veterinarian or can they put the proper label on the outside of the
plastic bucket? (These tubes are placed in a clear plastic bag and the bag is
then placed in a plastic bucket, by the manufacturer.)
No. It would be acceptable to put the label on the outside of the plastic
bucket.
(b) The manufacturer and Pharmacia recommend putting the label on the side of
the bucket.
FDA would agree with that recommendation.
(c) What if the individual tubes get scattered and the bucket, with the label
attached, cannot be found?
This drug (intra-mammary infusion tubes) would not be properly labeled and would
constitute a two-point debit under Item 15r(c). It is similar to a 12-pack of
intra-mammary infusion tubes not being labeled and the box cannot be found.
42. PMO-Section 7, Item 15r
Is 15(e) on Form FDA 2359a-DAIRY FARM INSPECTION REPORT the correct place to
mark prohibited drugs, i.e., Nitrofurazone, Baytril, Chloramphenicol
Clenbuterol, DMSO, Dipyrone, Colloidal Silver, etc.?
Yes.
43. PMO-Section 7, Item 16r
If you have more than two hand-wash basins in the barn, do you need hot and cold
water at both basins?
No. The hand washing facility that is determined to be the most conveniently
located to the milkhouse, milking barn, stable, parlor and flush toilet must be
properly equipped with a lavatory fixture, supplied with hot and cold, or warm
running water, soap or detergent and individual sanitary towels. While a hand
washing facility is not required to be in the milkhouse it must be convenient to
all three areas at any given time. Professional judgment should be used in
determining if more than one such facility is needed to achieve convenience to
all three areas.
44. PMO-Section 7, Item 18r
Are temperature-recording devices required on all farm bulk milk tanks?
No. Temperature-recording devices are required on all farm bulk milk tanks
manufactured after January 1, 2000.
45. PMO-Section 7, Items 18r and 12p; and Appendix H.
May a paperless method of recording temperatures be used on raw milk storage
tanks in plants or on farms?
Yes. Paperless recording methods may be used, if all the requirements of the
PMO, including Items 18r, 12p, and Appendix H. are met, and the method is
acceptable to the Regulatory Agency.
46. PMO-Section 7, Item 18r and MMSR
Some States have laws that require all farm bulk tanks to have recording
thermometers. Do the recording thermometer requirements of Item 18r include all
farm bulk tanks or just the tanks manufactured after January 1, 2000?
This one point violation regarding recording thermometers refers only to those
bulk tanks manufactured after January 1, 2000.
47. PMO-Section 7, Item 19r
Must the outside hose port door be self-closing?
No. The exterior hose port door must be kept closed when not in use; however,
if it were left open, when not in use, it would be considered a violation of
Item 19r(c).
48. PMO-Section 7, Item 12p
Which Item on Form FDA 2359-MILK PLANT INSPECTION REPORT is debited, when during
the course of a plant rating or check rating, the CIP charts indicate that
storage vessels, which are required to be emptied and cleaned at least every 72
hours, are not meeting this minimum cleaning requirement?
12(a) and (c).
49. PMO-Section 7, Item 12p and Appendix B.
Are milk tank truck cleaning facilities required to wash tanker hoses and milk
pumps? Can a milk tank truck cleaning facility affix a cleaning and sanitizing
tag, if the tanker hoses and pumps are not cleaned?
No to both questions.
50. PMO-Section 7, Item 12p
Appendix B. requires milk tank trucks to be re-sanitized when the time elapsed
after cleaning and sanitizing and before first use exceeds 72 hours. Are milk
storage tanks required to be re-sanitized, if they also exceed 72 hours?
No. It is recommended that the plant re-sanitize these storage tanks when plant
operations result in an extended time interval before the tank is next used.
51. PMO-Section 7, Item 12p and Appendix H.
Can a single temperature-sensing element be used to provide temperature signals
to the digital indicating and analog recording thermometers in raw milk storage
tanks where 7-day recording devices are required?
Yes.
52. PMO-Section 7, Item 12p and Appendix H.
Can electronic recording thermometers with digital LED reference readouts be
used to meet both the indicating and recording thermometer requirements in raw
or heat treated milk storage tanks where recording devices are required?
Yes. If they meet the requirements of Appendix H.
53. PMO-Section 7, Items 12p and 18p
What are the time limits for the storage of bulk pasteurized milk prior to
packaging? Item 18p of the PMO states that packaging shall be done "without
undue delay". How does this comply with Item 12p of the PMO that allows
pasteurized storage tanks to be emptied and cleaned at 72-hour intervals?
Even though Item 12p of the PMO requires that milk storage tanks be cleaned when
emptied and be emptied and cleaned at least every 72 hours, if it is determined
that a plant is routinely storing pasteurized milk for extended periods of time,
normally in excess of 24 hours, prior to packaging, then it is considered a
violation of Item 18p. Professional judgment must be used regarding unusual
circumstances that may occur, which may require the storage of pasteurized
product for longer than the 24 hour guidance prior to packaging.
54. PMO-Section 7, Item 12p and Appendix B.
If a milk tank truck delivers milk to a plant and the wash tag indicates that
the truck was last washed at a facility that was determined not to be permitted
as a milk tank truck cleaning facility, what should happen?
The plant shall not unload the milk tank truck. If these requirements are not
followed, Item 12p(b) on the Form FDA 2359 for the plant shall be debited.
Also, Appendix B. states: "A milk tank truck without proper cleaning and
sanitizing documentation shall not be loaded or unloaded until the proper
cleaning and sanitization can be verified."
55. PMO-Section 7, Item 12p and Appendix J.; and "SMEDP"
In a single service plant that manufactures several size containers, what
sampling frequency is acceptable?
Appendix J. of the PMO states: "During any consecutive six (6) months, at least
four (4) sample sets shall be collected in at least four (4) separate months,
except when three (3) months show a month containing two (2) sampling dates
separated by at least twenty (20) days, and analyzed at an Official, Commercial
or Industry Laboratory approved by the State Milk Laboratory Certifying Agency
specifically for the examinations required under these Standards.
A sample set from each manufacturing line, as defined in these Standards, shall
consist of a minimum of four (4) containers or closures when the rinse test is
used, or a minimum of four (4) 50-cm2 areas of surface when the swab test is
used.
"Manufacturing Line" shall mean a manufacturing process such as injection
molding, extrusion, blow-molding, etc."
If all of the containers are from the blow-mold process (manufacturing line),
one sample set per sampling event is sufficient. It is recommended that, if
different size containers and different machines are being utilized, they should
be sampled in a rotating fashion.
56. PMO-Section 7, Item 15p(A)
Does the PMO prohibit running a pasteurized juice product immediately prior to a
Grade "A" pasteurized milk product if the equipment is rinsed with pasteurized
water first?
No.
57. PMO-Section 7, Item 15p(B)
Within the definition of a pasteurized product, does it include cultured
products in relation to the utilization of a pasteurized water flush or water
that has undergone an equivalent process found acceptable by FDA and the State
Regulatory Agency? Is a cultured product considered a pasteurized product?
The answer is yes to both questions.
58. PMO-Section 7, Item 15p (B)
Are two steam blocks in series acceptable for separation of product and CIP
solution? If so, where is this in writing?
Yes. Refer to IMS-a-44, Proposal 131
59. PMO-Section 7, Item 16p(A)
What is the status of the Carpigiani-Coldelite Vat Pasteurizer?
This equipment has a 3-A Symbol as a vat pasteurizer; however, it does not meet
several of the requirements of the Standard nor the PMO. We understand that
several problems have been identified from the field reviews conducted by State
Regulators and FDA Regional Milk Specialists, and a challenge has been made
addressing the validity of this vat pasteurizer's 3-A Symbol.
60. PMO-Section 7, Item 16p(A) and (B); and Appendices H. and I.
Digital indicating thermometers located on pasteurization pipelines are blinking
off when a walkie-talkie is keyed up by the device. Is this a problem?
Yes. The specifications for digital indicating thermometers located on
pasteurization pipelines are contained in Appendix H. of the PMO. These
specifications require that these devices be tested to determine the effects of
electrostatic discharge, power fluctuation, conductive emission and
susceptibility, and radioactive emission and susceptibility. Digital indicating
thermometers on pasteurization pipelines must conform to performance level
characteristics of industrial devices. This type of thermometer must blank out
when the self-diagnostic circuitry fails. The cause of these failures must be
identified and steps taken to eliminate them by repair or replacement.
All hand held communication devices used near digital indicating thermometers
must be tested.
Appendix I., Test 15 of the PMO states:
"Corrective Action: Have the facility check for shielding, grounding and other
installation concerns and retest. Until a solution, acceptable to the
Regulatory Agency, can be found that does not adversely affect the public health
safeguards, the hand-held device may not be used in the area of the public
health safeguards."
NOTE: "Radio free zones" are not acceptable as long-term solutions to violative
communication devices
Refer to IMS-a-44, Proposal 162
"Frequency: Upon installation, alteration of the electronic controls, every
three (3) months thereafter, and whenever the type or wattage of the hand-held
communication device(s) used in that facility is changed. Once a hand-held
communication device has been shown to cause a given electronic control device
to react adversely, the test does not have to be repeated every three (3) months
using that specific hand-held communication device on the adversely affected
electronic control device. If the electronic control device is altered or there
is a change in the hand-held communication device used, the electronic control
device would be required to be tested."
61. PMO-Section 7, Item 16p(B)
What is the status of Moyno pumps?
These pumps were reviewed by FDA and found to be acceptable product pumps. At
one time they were being field tested to see if they could serve as a timing
pump in a HTST system. The study results from industry have not been submitted
to FDA for review.
62. PMO-Section 7, Item 16p(D)
What are the requirements of HTST in-line standardization, located downstream
from the balance tank and upstream from the raw regenerator?
They must be installed so they are not capable of negatively affecting the raw
side regenerator pressures during operation or shutdown. Systems not meeting
these requirements would be considered in violation of Item 16p(D) of the PMO.
63. PMO-Section 7, Item 16p(E)
In an HTST system, which is mechanically (circulation) cleaned, must the
identity of the specific chemical sanitizer be annotated on the HTST chart?
No.
64. PMO-Section 7, Item 17p
Is tower water acceptable in a secondary cooling loop? I understand that it is
allowed with the DASI system but not with others. Can you explain why?
Yes. Refer to IMS-a-44, Proposal 147
In the DASI system that was reviewed, the water that is cooled by the tower
water in a water-to-water plate heat exchanger, is not exposed to plates, which
are opposite of raw, pasteurized or aseptic product until after it has been
superheated with steam.
Other piping arrangements for other DASI systems, or any other system, must be
individually evaluated.
65. PMO-Section 7, Item 17p and Appendix H.
Electronic recording thermometers are available that are equipped with a digital
LED reference readout in addition to the analog recording device. Is this
digital reference LED readout acceptable for indicating thermometer purposes on
milk storage tanks where mercury-in-glass or bi-metal thermometers have
traditionally been used?
Yes.
66. PMO-Section 7, Item 17p and Appendix H.
Are digital indicating thermometers required to be self-diagnostic, if used in
milk storage tanks where mercury-in-glass or bi-metal thermometers have
traditionally been used?
No.
67. PMO-Section 11
Can a State allow a non-listed plant to ship Grade "A" milk and milk products to
the United States Virgin Islands (USVI), a U.S. protectorate?
The USVI is not a participant in the NCIMS program. It would be up to the USVI
to determine if they will accept Grade "A" milk and milk products from non-IMS
listed sources.
68. PMO-Appendix B.
The PMO requires that an examination, approved by the Regulatory Agency, shall
be administered at the conclusion of the training program. Can this examination
be administered by industry?
Yes. If industry is allowed to provide the training and administer the
examination, it must be approved by or conducted under the supervision of the
Regulatory Agency. The examination itself must be approved by the Regulatory
Agency and must be composed of a minimum of twenty (20) total questions broken
down in the appropriate areas as cited in Appendix B.
69. PMO-Appendix B.
What specific information must be on the producer sample (vial) to comply with
IMS, FDA, and State Regulatory Regulations?
If a copy of the weight ticket accompanies the samples to the laboratory, only
the producer's identification, i.e., name or number, and the date of pickup
needs to be on the sample container. If the weight ticket does not accompany
the samples to the lab, then the producer's identification, temperature, time
and date of pickup and bulk milk hauler/sampler's identification must be on the
sample container. (Refer to Item 18(p.) on Form FDA 2399a.)
70. PMO-Appendix B.
This question came up during a recent Sampling Surveillance Officer (SSO)
certification. I have interpreted the thermometer calibration to require a
comparison to a known thermometer at least every 6 months. This information
would be required to be attached to the bulk milk hauler/sampler's thermometer
or be maintained in a log available to the inspector. I have also considered
this calibration requirement to include State inspectors, when their
thermometers are used for regulatory purposes. The use of an ice bath is
appropriate between calibrations; however, if a calibration problem were found,
the thermometer would need to be recalibrated with a known thermometer. I was
of the impression and have always asked that these pocket thermometers be
checked against some kind of an accurate certified thermometer. Normal process
was to have them checked in a certified laboratory.
(a) Is the six (6) month comparison required to be done in a certified (milk or
drug) IMS lab?
No. The thermometers may be compared to a thermometer that has been calibrated,
as accurate, by a traceable thermometer in a laboratory that is either a
Regulatory Laboratory or a laboratory acceptable to the Regulatory Agency.
(b) Are other laboratories acceptable provided they have traceable thermometers?
Yes. It must be done in a laboratory acceptable to the Regulatory Agency that
uses a National Institute of Standards and Technology (NIST) thermometer or NIST
traceable thermometer.
(c) What is a known thermometer? Could an inspector's calibrated thermometer be
used to calibrate bulk milk hauler/sampler's thermometers?
The known thermometer for official calibration is an NIST thermometer or NIST
traceable thermometer.
(d) Does an ice bath play any role in thermometer calibrations required by
Appendix B.? It was revealed that several regulatory folks started to certify
their own thermometers in an ice water bath. This has now spread to farm bulk
milk hauler/samplers.
The ice bath can be used to check the inspector's thermometer against an NIST
thermometer or NIST traceable thermometer at refrigeration temperatures. An ice
bath may be used as one of the parameters for an unofficial check between the
required six (6) month official calibrations, if an individual has a question
about the calibration of the thermometer(s) that they are using. This would be
completely unofficial, and we would recommend, that whenever they have any
questions about the calibration of their thermometers, they have them officially
calibrated in an appropriate lab using an NIST thermometer or NIST traceable
thermometer.
71. PMO, Appendix B.
May the dairy farm owner be part of the chain-of-custody for his bulk tank
sample, once it is collected by a licensed bulk milk hauler/sampler? They are
currently packing the sample for courier transportation to the official lab.
Generally no; however, if the farmer is a permitted bulk milk hauler/sampler,
they may be allowed to take and pack the sample, or deliver the sample to the
laboratory.
72. PMO-Appendix J.
Can a single-service container/closure manufacturer, which has not manufactured
a dairy related single-service article for 1-3 years be denied a listing?
The final determination is left up to the Rating Agency that lists this
facility. It is recommended that this determination be made in consultation
with the Regulatory Agency.
73. PMO-Appendix J.
Do regrind bins, at the end of the conveyor, and regrind chutes that collect the
heads and tails of the jugs, off the blow mold machines, have to be covered or
shielded during use?
When in operation, collection containers, used at the blow mold machines to
collect discarded containers, are not required to be covered nor shielded. The
regrind chutes, located directly off the cutter that route regrind materials
directly to the grinder, are required to have all openings either covered or
shielded.
Containers used for the storage of regrind, intended for reuse, shall be
covered. When collection containers, located at the blow mold machines, are
moved to the side and are no longer engaged in receiving materials to be
reground from the blow mold machines, and the contents are not immediately sent
to the grinder, they become storage containers and must be covered at this time.
74. PMO-Appendix J.
Can a single service manufacturer re-use cardboard dividers placed against the
mouth of blow mold containers if the containers are going to be rinsed with a
sanitizing solution prior to filling?
No.
75. PMO-Appendix N.; and M-I-01-4
(a) M-I-01-4 allows for the visual reading of drug residue tests, provided that
the analyst has passed an on-site Laboratory Evaluation Officer's (LEO)
evaluation and has passed the annual proficiency test. I have a receiving
laboratory that routinely uses a reader when conducting tanker drug residue
tests. The test being utilized is capable of being read visually, such as
IDEXX, SNAP or Charm SL. Do I have to certify all or some of my analysts to
read the test results visually for the SNAP test in case my reader goes down?
First of all, CHARM SL was not validated as a visual test. It may not be read
visually. It is a facility's option to seek certification or approval of
analysts to read the test results visually, but purchasing a backup would be
preferable.
(b) Do I have to keep a backup reader on site? And what happens in that
emergency situation, if I find that the backup reader that has been setting on
the shelf for months is not operable?
No. But having a backup on-site is a good idea. If you have a backup, use the
backup and main reader interchangeably, don't wait to find out that the backup
doesn't work.
(c) Can I get emergency authorization to visually read test results until a
replacement reader can be delivered overnight?
No.
76. PMO-Appendix N.
Please explain the 4 options for sample collection and testing under the
quarterly 10% sampling program for Regulatory under Appendix N.
(1) Collect samples quarterly from 10% of the tankers received at the plant on a
given day. These samples have to be analyzed in an Official Laboratory using
the same test as Industry.
(2) Certify all screening analysts at the screening site. Then, the Regulatory
Agency is not required to collect the quarterly 10% samples.
(3) On a quarterly basis, have screening analysts at the screening sites analyze
unknown samples, which are prepared by the LEO.
(4) A CIS may analyze the same sample(s) that the screening analyst analyzed at
the same screening site. (This is a variation of # 1.)
77. PMO-Appendix N.
(a) If the LEO prepares unknown samples for the Industry Analysis to test for
compliance with the quarterly 10% Appendix "N" samples, can an inspector take
those samples to the screening facility for testing or does the LEO have to
deliver them?
An inspector, trained by the LEO, may: 1.) Take those samples to the site and
observe the analysis. The inspector must be familiar with the procedure and must
be able to adequately review it, as the analysts test the samples. Just
delivery of the samples alone is not enough; or 2.) It would be acceptable for
an LEO to provide unknowns to an inspector, without a key, and have the
inspector report back the results to the LEO. The LEO could then indicate if
the testing was satisfactory or not. There would be no need for training the
inspector, only that the inspector be present during the testing.
(b) If the screening facility is testing unknowns to satisfy the quarterly 10%
audit requirement, how many unknowns are required?
The Regulatory Agency should test a minimum of each Beta-lactam for which
concentrates are provided. There should be the same number of positive and
negative samples provided.
(c) What happens if the results are incorrect? What happens if audit samples
fail?
If the analyst fails, he/she cannot test. With 5-10 samples, you can miss one.
If you have less than five samples, you can't miss any. If an analyst fails,
he/she cannot screen incoming milk samples until he/she has been retrained.
(d) Could the Regulatory Agency go in once a quarter and ask the Industry
Analysts to run a positive and a negative control instead of bringing in
unknowns?
No.
(e) Can you keep missing one each time?
Yes. You can miss one if you have at least 5 samples.
(f) What if the analyst fails in more than one quarter?
If an analyst fails more than once, he/she cannot continue to test, until he/she
has been retrained, retested and demonstrated competence.
(g) Are we looking at the analysts that day or must we test all screening
analysts?
All of them. This option is a viable option for some States, so it is not valid
to eliminate it; however, if all analysts cannot be tested at a particular site
on the same day, the State will have to use one of the other options to meet its
10% Audit needs.
78. PMO-Appendix N.
If a tanker load confirms positive for antibiotics, but the producer samples,
both composite and bacteria, are confirmed negative, can a second tanker sample
be taken for testing to eliminate the possibility of an improper first tanker
sample?
AND
If the second tanker sample is negative, can the load be utilized for human
consumption? What paperwork would need to be completed?
No to both questions. In order for a tanker to be confirmed positive, nine (9)
tests have already been performed. It is too late to determine that the
original sample is not representative. The tanker might be utilized if the
company or State has a diversion protocol acceptable to the State and FDA's
Center for Veterinary Medicine (CVM) for the diversion to animal feed, but it
cannot be processed for human food. An investigation of why the tanker was
positive and the producers were negative needs to be conducted.
79. PMO-Appendices B. and N.; and M-a-86 (Revision 3)
A presumptive positive tanker sample is found at the plant. Does that sample
have to travel with the load, if confirmation is done at a second location? How
do you assure sample integrity?
Not necessarily, it is up to the direction of the State Regulatory Agency.
M-a-86 (Revision 3) states: "The presumptive positive load may be re-sampled
(at the direction of the State Regulatory Agency) prior to analysis with the
same or equivalent test (M-I-96-10, latest revision), as was used to obtain the
presumptive positive result."
Sample integrity (chain-of-custody) must be performed in accordance with
Appendix B. of the PMO.
80. PMO-Appendix N.
Who is responsible for submitting a proposed protocol for the diversion of
antibiotic milk to animal feed? Is it the producer that provides the antibiotic
milk or the person that receives the antibiotic milk and feeds it to the
animals, which are eventually sold by the feeder?
The most responsible party/person for the introduction of the food product into
interstate commerce is the person responsible for the diversion protocol and
adhering to it. In this case the live animal is the food product.
All persons involved in the introduction of the food, animals in this case, into
interstate commerce are responsible for adhering to an agreed-to protocol for
the use of antibiotic positive milk for animal feed or a feed ingredient. As in
all compliance cases we look to the most responsible person or persons in the
firm. The few diversion protocols that FDA has not objected to involve only
Beta-lactam positive milk. The reason is that the methodology and focus in the
milk industry is on Beta-lactam. Fortunately, we do have FDA accepted methods,
rapid screening tests, for other drugs, i.e., sulfonamides, chloramphenicol,
tetracyclines, etc.
A second point is that FDA/CVM will review a submitted plan/protocol for its
ability to protect human food. This involves a review by our experts in human
food safety, animal feeds, and compliance. We do not "approve" such
plans/protocols for diversion. If the plan is acceptable in terms of protecting
human food and animal health we issue a letter of "non-objection". That letter
also directs the submitter of the protocol to obtain clearance from both the
State Milk Regulatory and Feed Control Agencies.
For further discussion, contact Dr. Michael R. Talley at mtalley1@cvm.fda.gov.
81. PMO-Appendix N.; and M-a-86 (Revision 3)
Is a single 2 ounce raw milk sample sufficient to run all of the tests required
for the new presumptive and confirmation protocols in M-a-86 (Revision 3)?
Yes.
82. PMO, Appendix N.
May a plant just run one test from a tanker for Beta-lactam, get a positive, and
reject the load?
No. However, if the plant owns the milk, then they may reject the milk on a
presumptive positive result (5 tests-Initial, plus running the initial sample in
duplicate with positive and negative controls). However, if the plant does not
own the milk, the plant laboratory must test the milk in accordance with
Appendix N. guidelines and confirm the presumptive positive sample by running
this initial sample in duplicate with positive and negative controls prior to
rejection. In both cases the Regulatory Agency must be notified.
83. PMO-Appendix N. and 2400 Series Forms
If an Appendix N. testing facility is not IMS and performs the SNAP test, are
they required to have a reader/printer?
No. At the present time, the older version of the SNAP test can be read
visually as well as with a reader/printer.
84. DMO-Section 1 and THE CODE OF FEDERAL REGULATIONS (CFR)
May milk protein concentrates (MPC) be used in the manufacture of Grade "A" milk
products?
Yes. If the MPC is from a Grade "A" IMS Listed source and the Standard of
Identity for the Grade "A" milk product(s) provides for the use of MPC.
85. DMO-Sections 1, 4, 6 and 7; M-a-83 and M-I-02-8
(a) Can Blended Dry Dairy Products, that serve as stabilizers, meet the
definition of dry milk products and or dry whey products included in the DMO?
Yes.
(b) Are all of the dairy product ingredients required to be Grade "A" if the
blend is to be utilized as an ingredient in a Grade "A" milk or milk product?
Yes. However, there currently are three exceptions. These are:
(1) M-a-83 describes an exception allowing up to 5% of the powdered dairy blend
that is intended to serve as an ingredient in another dairy product, such as
media for starter cultures used to produce various cultured dairy products and
cottage cheese dressing mixes, provided that the non-Grade "A" product is
functional and is not available in a Grade "A" form, i.e., sodium caseinate used
as a stabilizer;
(2) M-a-83 also refers to a previous acceptance of non-Grade "A" dairy
ingredients in small cans of freeze-dried starter culture; and
(3) FDA has accepted a calcium supplement derived from non-Grade "A" whey.
If a powdered blend is to be used as an ingredient in the production of IMS
listed Grade "A" milk or milk products, the blend must be labeled Grade "A", and
the plant(s) where the Grade "A" dairy powders are manufactured and the facility
where the powder is blended and packaged must each have an acceptable IMS
listing.
(c) Do the blended dairy products need to be sampled and tested?
Yes. The DMO states: "During any consecutive six (6) months, at least four (4)
samples of each Grade "A" dry milk product, four (4) samples of each Grade "A"
condensed and Grade "A" dry whey product being manufactured and defined in this
Ordinance, shall be collected in at least four (4) separate months, except when
three (3) months show a month containing two (2) sampling dates separated by at
least twenty (20) days, from every milk plant, by the Regulatory Agency."
(Refer to M-I-02-8 for testing criteria for bacterial and drug testing.)
(d) Are there laboratory standards for these products?
Yes. Laboratory standards for these products are found in Section 7, Table 1 of
the DMO.
(e) What are the consequences during State Ratings and FDA Check Ratings, if
these products are not sampled and tested?
If there are not four (4) samples of each product in the six (6) month period
preceding the State Rating or FDA Check Rating, the plant would loose fifteen
(15) points (ten (10) for coliform and five (5) for bacteria) for each product
that is missing the required number of samples. This fifteen (15) point debit
would be prorated based on the production volume of each product in violation.
86. DMO-SECTION 6
(a) Is phosphatase testing required on modified whey products; such as, dried or
condensed whey protein concentrate?
No. None of the phosphatase methods have been validated for whey and whey
products. If a Regulatory Agency chooses an inappropriate product to be tested
or uses an unapproved test for "Official Regulatory" testing and the result is
violative, regulatory officials must act on the result. Appropriate action and
a follow-up investigation are required to resolve the result.
(b) Is there a percent (%) concentration that interferes with the phosphatase
results?
There is not a standard definition for whey. It is not possible to specify a
percentage. We are not aware of any data on which to base an answer to this
specific part of this question.
87. DMO-Section 7, Items 12p and 15p(B); and Appendix D.-Part V
(a) Can you sanitize with cow water?
Yes. Cow water that meets all the requirements of Appendix D., Part V., Level I
of the DMO, may be used for all potable water uses in the plant.
(b) Can you flush pasteurized milk lines or push pasteurized product with cow
water?
Yes. However, cow water, if used to push pasteurized milk or milk products,
must initially comply with Appendix D., Part V., Level I of the DMO and then
must comply with the requirements of Item 15p(B)2.
(c) May cow water from a whey feed plant (non-grade A) be used in a Grade "A"
receiving room or milk plant?
No.
88. DMO-Section 7, Item 15(B)
Do the PMO requirements for a water flush for separation of products apply to
the DMO?
Yes. Products are normally pasteurized as they enter the condenser; therefore,
water following them would also be pasteurized. If condensed product is cooled
and stored prior to drying and pushed or flushed from the storage tank with
water, or if water is used to flush between products entering the dryer, the
requirements of 15p(B) apply. The only exceptions are water used to perform
flushes of the condensing equipment during emergency shutdown and fire
suppression systems in drying equipment.
89. PROCEDURES
How often does an LEO have to attend the Regional Milk Seminar?
When Regional Milk Seminars are offered in the LEO's Region, they must attend.
However, if it is not possible to attend the meeting in their Region, they may
attend another Regional Milk Seminar that year to fulfill that requirement.
90. PROCEDURES
Are all LEO(s) in a State required to attend a Regional Seminar when held in
their Region every year, or may a State be represented by one LEO every year at
a Regional Seminar?
The State must be represented by at least one LEO at Annual Regional Milk
Seminars.
91. PROCEDURES
Can Consultants still do Single Service Inspection/Listings for U.S. firms?
Consultants can only perform the routine inspections, they cannot do the
listing. Listings can only be done by qualified State Rating Officers.
92. MMSR-Section C, Item 2(a)
When calculating partial debits for individual pasteurizers, is it true that the
debit is "weighted" based on the volume of milk processed in the pasteurizer,
which is non-compliant?
Yes.
93. MMSR, Section D
What is the uniform method for determining the number of equipment tests for
computing the enforcement rating, Part II on pasteurization testing
requirements?
The computation is based on the number of pasteurizers (vat, HTST, and HHST)
that the plant is using for Grade "A" milk and milk products, in conjunction
with the number of quarterly tests required since the last State Rating.
Therefore, if the plant has 4 HTST units and the rating period is twelve months,
then a total of 16 tests would be required for that rating period. If only 14
were completed successfully and/or at the required frequency, the Regulatory
Agency would get credit for 14 of 16 tests (87.5%) of Number 5 (15 Weight) or
13.1 Credit. If serious violations are found that require correction and
testing verification, or if broken regulatory seals are reported that require
testing verification, the additional equipment tests needed would be added to
the total number of required tests. The number of these additional tests that
are accomplished would be added to the number of tests performed.
94. MMSR-Sections D and H and the Appendix
How are we calculating Item 4-Interpretation, under PLANTS, of the Report of
Enforcement Methods?
For the Item(s) that was determined not to be properly interpreted from the last
inspection report or an Item(s) that was inappropriately debited on previous
inspection reports, reviewed back to the last State Rating date, the weight
(point value) assigned to that Item(s) on Form FDA 2359L-STATUS OF MILK PLANTS
would be subtracted from 100.
For Example: A violation of Item 16b(2)(d), a 15 point debit, was observed
during a State Rating or FDA Check Rating but was not debited on the last
inspection and the violation was determined to exist at the time of the last
inspection. Therefore, 100-15 = 85 (.85 would be the figure placed in the
percent complying column for Item 4-Interpretation), which would calculate out
to a credit of 8.5 for Item 4 for the milk plant. (Refer to Section H-Examples
of Completed Rating Forms of the 2001 MMSR.)
NOTE: This method applies to PLANT ratings only. Farms are determined on a
farm-by-farm basis.
95. MMSR-Section F
(a) What date(s) should be recorded on the 2359i, the date you start a rating or
the date you finish?
The date(s) that the actual rating (inspection) of farm(s) and/or a plant was
conducted should be indicated on the 2359i. If it took two days to complete the
rating, then the actual dates shall be recorded, i.e., 9/17-18/2003.
(b) What date is entered in the "Earliest Rating Date" section and how is this
determined?
The first day of the actual rating (inspection) of either the farm(s) and/or a
plant is the "Earliest Rating Date", and this date shall be recorded in this
section. The earliest rating date is determined, as the first day of the actual
rating (inspection), not when you may have instituted the record review portion
of the rating.
(c) When does an actual rating commence, is it on the date of inspection of a
farm(s) or plant or on the commencement of reviewing records prior to the
inspection? Since the enforcement is part of the rating, can this count as the
beginning of the rating?
The date of inspection. Reviewing records prior to the inspection would not be
considered as the beginning of the rating and would not be utilized in
determining the "Earliest Rating Date" for that section of the 2359i.
(d) What if the rating takes more than one day?
The actual days that it takes to complete the rating (inspection) portion of the
rating should be listed under the "Date of Inspection" for either the farms or
plant, i.e. 9/17-18/2002. The date(s) recorded under the Enforcement Section
should be the actual dates that the records were review.
96. EML
(a) How is an analyst certified?
There are two routes:
(1) An onsite survey every two years for State certified (every three years for
Federal certification); and
(2) Annual proficiencies.
Conditional certification can be granted with successful participation in (1) or
(2). Option 2 is for established laboratories only. New laboratories must be
on-site surveyed before they can receive annual proficiencies.
(b) Who does it?
A State or Federal LEO.
(c) How is it documented?
By written records, as specified in the EML.
(d) What is the difference between certified and industry labs?
A certified lab is able to perform analysis for regulatory purposes. A lab that
is certified, can be industry, private or State. Certified industry labs are
not allowed to analyze Grade "A" finished milk and milk products.
97. EML
What are the details of the annual proficiency tests? What are the normal
annual proficiencies?
Refer to the EML for details. You may obtain information from Laboratory
Quality Assurance Branch (LQAB) also.
98. CFSAN INTERNET
How can I get an electronic copy of the Grade "A" IMS Program documents, coded
memoranda, etc.?
* www.fda.gov/cfsan
* Click on Special Interest Groups
* Click on Federal/State Food Programs (Milk, Retail & Shellfish)
* Click on Milk Safety References
99. SMEDP
Has anyone evaluated "whirlpak" bags versus vials for advantages regarding
better aseptic transfer, sample mixing, etc.?
When properly used, both are acceptable under Chapter 3 of Standards Methods.
1
M-I-03-13 1 October 3, 2003
