HHS:PHS:FDA:CFSAN:OC:DCP:MSB
200 C Street, SW
Washington DC
M-I-00-08
December 18, 2000
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Questions and Answers from FY 2000 510-Special Problems in Milk
Protection Courses
Following are the questions and answers from the 510-Special Problems in Milk
Protection Courses held in Madison, WI on August 21-25, 2000 and Baton Rouge, LA
on September 11-15, 2000.
In accordance with procedures established through the National Conference on
Interstate Milk Shipments, 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 judgement 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 is also available on the FDA Web site at http://cfsan.fda.gov and
should be widely distributed to representatives of the dairy industry and other
interested parties.
Joseph M. Smucker, Chief
Milk Safety Branch
QUESTIONS AND ANSWERS
510 COURSES
MADISON, WI
AUGUST 21-25, 2000
and
BATON ROUGE, LA
SEPTEMBER 11-15, 2000
1. PMO, Section 1-Definitions and Appendix L-Standards of Identity for Milk and
Milk Products
A Grade "A" plant (on a farm) is using a Reverse Osmosis (RO) process on
unpasteurized whole milk. What Grade "A" products can contain this RO milk as
an ingredient?
In general, Grade "A" milk concentrated in RO equipment can be used as an
ingredient in a Grade "A" milk product if the Standard of Identity for that
product provides for the use of concentrated milk, or if the applicable section
of the Standard of Identity for the product has been stayed. We have reviewed
the Standards of Identity for yogurt, cottage cheese and sour cream and believe
that milk concentrated, using an RO process, can be used in those product
formulations.
2. PMO, Sections 3-Permits and 5-Inspection of Dairy Farms and Milk Plants and
Methods of Making Sanitation Ratings of Milk Shippers (MMSR)
Do Grade "B" (Manufacturing) plants that wash Grade A tankers need to be IMS
Listed or just quarterly inspected?
Within the 1999 Revisions of MMSR and Procedures, there are no provisions for
the IMS Listing of Milk Tank Truck Cleaning Facilities.
With regard to inspection, yes, each Milk Tank Truck Cleaning Facility shall be
inspected by the regulatory agency prior to the issuance of a Grade "A" permit
and shall be inspected following the issuance of a permit at least once every 6
months. A Milk Tank Truck Cleaning
Facility is "any place, premise, or establishment, separate from a milk plant,
receiving or transfer station, where a milk tank truck is cleaned and
sanitized". Each Milk Tank Truck Cleaning Facility shall hold a valid Grade "A"
permit.
3. PMO, Section 6-Examination of Milk and Milk Products
Can the Delvo P 5 Pack test for detecting beta lactams be used with any fat
level (fat free, 1%, reduced fat and whole) of chocolate milk or just fat free
and whole chocolate milk as cited in M-I-99-3?
The Delvo P 5 Pack test can be used for the detection of beta lactams with any
fat level (fat free, 1%, reduced fat and whole) of chocolate milk.
4. PMO, Section 6-Examination of Milk and Milk Products
Can the Delvo P 5 Pack test for detecting beta lactams be used with any fat
level (fat free, 1%, reduced fat and whole) of any flavored milk, other than
chocolate milk?
No. The Delvo P 5 Pack test has not been tested for the detection of beta
lactams with any fat level (fat free, 1%, reduced fat and whole) of any flavored
milk other than chocolate milk.
5. PMO, Section 6-Examination of Milk and Milk Products, Appendix B-Milk
Sampling (Universal Sampling) and Appendix N-Drug Residue Testing and Farm
Surveillance
Do the universal representative samples, taken at the individual farms, have to
accompany the bulk milk pickup tanker to the receiving plant?
Section 6 of the PMO states: "All samples shall be collected and delivered to a
milk plant, receiving station, transfer station or other location approved by
the regulatory agency." M-a-86 (Revised), Implementation Date-08/01/2000 states:
"The representative sample(s) shall travel with the bulk milk pick-up tanker to
a designated location acceptable to the State Regulatory Agency."
6. PMO, Section 7, Items 1r-Abnormal Milk and 12r-Utensils and Equipment-Storage
The 1999 NCIMS Conference moved the evaluation of Abnormal Milk Handling
Equipment (i.e. "The Fresh Cow Bucket") to Item 1r which is a 5 point item.
Many State and Industry people think that improper storage (of a reasonably
clean fresh cow bucket) shouldn't be debited 5 points (use Professional
Judgement) but instead choose to evaluate it under Item 12r(a)-Storage of
Cleaned Equipment (2 points). I understand their intent, but I believe the
Conference put everything for fresh cow buckets under Item 1r. What is
correct?
Evaluation of abnormal milk handling equipment was moved to Item 1r to deal with
the issue of cow-to-cow transfer of infections. Therefore, cleaning, repair and
drainage concerns regarding this equipment are evaluated under Item 1r. If
storage of this equipment is contributing to a cleaning (housekeeping) concern
in the milking area or milkhouse, this is evaluated under Item 3r or 6r,
respectively.
7. PMO, Section 7, Item 3r-Milking Barn, Stable or Parlor-Cleanliness or
6r-Milkhouse-Cleanliness
Are milker claws stored in the parlor (exterior dirty) still marked under Item
6r(a)?
Milker claws and all milking equipment is evaluated under Items 3r or 6r
depending on whether it is located in the milking area or milkhouse,
respectively.
NOTE: This is a change from previous guidance and is intended to simplify
evaluating the cleanliness of the outside of milking and related equipment.
8. PMO, Section 7, Item 5r-Milkhouse-Construction and Facilities-Lighting and
Ventilation (d)
Is a light fixture over the milk tank opening still in violation of lighting
fixtures properly installed, Item 5r-Lighting and Ventilation (d)?
Yes
9. PMO, Section 7, Items 5r-Milkhouse-Construction and Facilities-Miscellaneous
Requirement (f) and 12p-Cleaning and Sanitizing of Containers and Equipment
Under the provisions for the direct-shipped (loading) milk on milk tank trucks
on the farm, without a shelter provided, where and how is the cleanliness of the
tankers to be determined (the manhole must be sealed after the truck has been
cleaned and sanitized)?
The preferable method would be to inspect the trucks at the plant following
cleaning and sanitizing and prior to the sealing of the manhole by the plant
employee.
NOTE: If the seal is missing from the manhole during storage or filling, at the
farm, it would be debitable under Item 5r-Miscellaneous Requirements (f). It is
the producer's responsibility to make sure the tanker is properly sealed prior
to use.
10. PMO, Section 7, Item 5r-Milkhouse-Construction and Facilities-Miscellaneous
Requirement (f)
Can a properly installed flow meter be used in place of the required liquid
level sensor device for the milk tank trucks cited in Question 9?
The requirement of the PMO to prevent the overflow of milk is to have the liquid
level sensor device deactivate the milk pump or sound an alarmed when activated.
If a piece of equipment can be installed to meet these requirements and be of
sanitary design it would be acceptable.
11. PMO, Section 7, Item 6r-Milkhouse-Cleanliness
Is abnormal milk stored in the milkhouse, during non-milking times, still
evaluated under Item 6r(b)?
Yes
12. PMO, Section 7, Item 8r-Water Supply
Two (2) separate dairy farms are both on the same well. Should a water sample
be taken from each milkhouse? The milkhouses are the points of use.
If this distribution system does not have separate storage reservoirs or other
unique features in the system, a single sample may be representative of the
individual water system. The results from this single sample must be included
in the records for each permitted dairy farm.
13. PMO, Section 7, Item 9r-Utensils and Equipment-Construction
Are rolled-on fittings on farm pipelines allowed or do they have to be welded as
per 3A? (Are they to be debited?)
Yes. Roll-on fittings are allowed and if in proper repair they are not debited.
NOTE: Effective January 2001, 3A Practice #606- 3A Accepted Practices For The
Design, Fabrication, and Installation of Milking and Milk Handling Equipment
will not allow roll-on fittings in installations claiming to meet the
requirements of this practice.
14. PMO, Section 7, Item 12r-Utensils and Equipment -Storage
Do single-service filters, stored in a properly protected and clean container,
have to remain in their original box or can they be removed and placed in a
separate container?
This would be acceptable if the filters can be removed and stored in a sanitary
manner and the container is kept clean and in good repair.
15. PMO, Section 7, Item 14r-Protection from Contamination
Is a full sized tee (same diameter as the uptake line), which is uncapped during
milking, acceptable physical separation between the CIP and milk system? The
uptake line extends below the flood level of the wash vat.
FDA has not objected to this if the tee is appropriately located above the flood
level of the wash vat.
16. PMO, Section 7, Item 14r-Protection from Contamination
A bulk milk tank is bulk headed into the milkhouse with the agitator located
either outside or in an area that does not meet milkhouse standards. This
agitator has a rubber boot or slinger cover to protect the opening through which
the agitator shaft enters the tank. An appropriate sanitary seal or cover is
needed to completely protect the opening and which extends from the bottom of
the agitator motor support base to the outside surface of the bulk tank. Is it
acceptable to use a cover or seal that is not manufactured by a tank
manufacturer, i.e., a clear plastic cover, that is tight-fitting and adequately
protects the opening and meets the requirements listed above? Does this cover
have to be clear so that the boot or slinger can be visually observed?
Yes, if it meets the conditions described below, either a manufacturer's cover
or an appropriate cover, designed by the producer or installer, can be
acceptable.
We would recommend, but not require, that the cover be clear so that the boot or
slinger can be observed and also to observe if the agitator motor is leaking
oil.
A cover used in place of a properly designed sanitary seal must adequately
protect the agitator shaft opening into the tank. It must be tight fitting. It
must be constructed to be easily accessible for inspection or must be clear so
that visible inspection is possible. If special tools are needed to disassemble
an opaque cover for inspection, they must be provided in or convenient to the
milkhouse. Side seams, top and bottom fittings must be sealed or properly
gasketed to make a tight seal. The surfaces inside the cover must meet product
contact requirements, be constructed to free drain back into the tank and be
kept clean.
17. PMO, Section 7, Item 18r-Raw Milk Cooling
If a farm installs a new bulk milk tank (manufactured after 1/1/2000) and does
not have a temperature-recording device, where is this Item debited?
Raw milk cooling would be debited under Item 18r(a)-Raw Milk Cooling. This Item
should be evaluated during routine regulatory inspections; however, during state
ratings and FDA check ratings this Item should not be debited until 12/01/2001.
18. PMO, Section 7, Item 18r-Raw Milk Cooling
When a recording chart is required under Item 18r and a dairyman does not
maintain bulk milk tank temperature recording charts, where is this debited?
This item would be debited under Item 18r(a)-Raw Milk Cooling. This Item should
be evaluated during routine regulatory inspections. However, during state
ratings and FDA check ratings this Item should not be debited until 12/01/2001.
The 1999 Revision of the PMO states: "Recording thermometer charts shall be
maintained on the premises for a period of a minimum of six (6) months and
available to the regulatory agency."
19. PMO, Section 7, Item 5p-Separate Rooms
If a "Bossy" cart washer is located in the cooler and is creating a potential
contamination problem to packaged milk and milk products that pass by it or are
stored next to it, what Item would it be evaluated under?
Item 5p-Separate Rooms
20. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment
If the milk tank truck(s), cited in Question 9, is determined to be dirty at the
plant, where is the tanker debited, plant where washed or the farm where stored?
As with other milk tank trucks delivering milk to the plant, they would be
evaluated under the plant.
21. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment
If a milk storage tank (pasteurized, raw or heat-treated) exceeds the 72 hour
requirement to be emptied and cleaned, where is it debited on Form FDA 2359-Milk
Plant Inspection Report?
Item 12(b)
22. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment
If the processing and packaging equipment does not meet the 24-hour cleaning and
sanitizing requirement, where is it debited?
Item 12p(a) and (c)
23. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment
Is a two (2) compartment wash vat required in the milk tank truck receiving
area? Can plastic or stainless steel buckets be utilized for the cleaning of
milk tank truck appurtenances in place of a two (2) compartment wash vat?
Adequate facilities must be available if milk tank truck appurtenances are being
manually washed in the receiving area. If the use of plastic or stainless steel
buckets can adequately clean and sanitize these appurtenances then this would be
acceptable. If not, then an appropriate two-(2) compartment wash vat would be
required in the receiving area.
24. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment
A pasteurized product tank is used as a surge tank (putting product in and
pulling product out throughout the day) and at the end of the day product is put
in the tank and stored for the next day's packaging. When does this tank need
to be cleaned?
This tank would need to be properly cleaned and sanitized after its use as a
surge tank and prior to product being put into the tank for storage purposes.
25. PMO, Section 7, Item 16p-Pasteurization and Aseptic Processing
Has FDA looked at the possibility of "cold pasteurization" of milk?
Yes. To date, FDA has not found an acceptable method.
26. PMO-Section 7, Item 17p-Cooling of Milk
M-I-00-7 (Question 12)-Can Grade "A" cottage cheese be filled "hot" (over 45°
F)? The PMO clearly states that pasteurized milk and milk products except those
to be cultured, are cooled immediately to 45° F or less in approved equipment...
FDA has evaluated one "hot fill" process for cottage cheese and accepted the
practice as safe.
Please define the "hot fill" (temperature requirements) process that has been
acceptable?
The details of the one process that has been evaluated and accepted are
proprietary and are not releasable. Any new processes or variations of the
process should be evaluated on a case-by-case basis.
27. PMO, Appendix I, Test 11
What is the proper method for determining the holding time on a steam injected
HHST pasteurizer?
Minimum holding tube length, normally based on pumping rate and holding tube
diameter, is determined in place of holding time using the appropriate
Subsection of PMO, Appendix I, Test 11.
28. PMO, Appendix N-Regulatory Responsibilities
Concern: M-a-79 states in the question and answer section at the top of page 2:
"Once AOAC reviewed and FDA accepted methods are available, methods shall be
appropriate for the drug being analyzed, and shall be capable of detecting the
same drugs at the same concentrations as the methods being used by the
industry."
What methods should be used to analyze these bulk milk pickup tanker audit
samples (10% quarterly regulatory sampling) by the regulatory agency? Since the
wording states "same drugs" and "same concentrations" then isn't it required to
be the "same" test?
NOTE: As was stated recently by FDA: "What must be considered is what is
actually stated and not the intent of the item." The word "equivalent" does not
exist in this section of the document.
Ideally the regulatory agency would use the same test kit as being used by
industry. However, FDA has allowed any test kit from M-I-96-10 to be used that
detects the same drugs.
Proposed wording for M-a-79 (Revision #2), August 11, 2000: "Methods used shall
be appropriate for the drug being analyzed, and shall be capable of detecting
the same drugs at or below the safe level or tolerance as the method being used
by industry." (See the latest revision of M-I-96-10.)
This regulatory agency analysis to audit industry farm bulk milk tanker
programs shall be performed in an Official or Officially Designated Laboratory
using a method from the latest revision of M-a-85.
29. MMSR, Section C-Rating Methods for Milk Plants
This section allows for the prorating of deficiencies in a milk plant that
affects only one type of packaging (paper, glass, single-service plastics,
multi-use plastics, dispenser, cottage cheese, sour cream or yogurt containers);
or the capping of these containers. Only the quantity of all products affected
by the deficiency, rather than the entire plant daily production is recorded and
used in the computation of the plant sanitation compliance rating. Can you
prorate by a specific type of paper machine, i.e., that machine only does a
specific type of paper container (Slim Line cartons) or only does school milk
size cartons?
Yes. You can prorate deficiencies that apply to only one type of paper package.
When a deficiency in a milk plant effects only one type of packaging or capping,
only the quantity (number of pounds) of all products affected by the deficiency
are debited and recorded for use in the computation of the plant sanitation
compliance rating.
30. Procedures, Section IV., B-State Responsibilities
Following a check rating that indicates that a re-rating (Producer Dairies-Raw
Milk) or a reinspection (Milk Plants, Receiving Stations and/or Transfer
Stations) is required, what date is used when determining a re-rating within
sixty (60) days or a reinspection within thirty (30) days is due? Is it the
first day of the check rating, last day of the check rating or the day that the
State Rating Agency is formally notified?
The date that the State Rating Agency is formally notified should be the date
that you use to determine when a re-rating (within sixty (60)) or a reinspection
(within thirty (30)) is due.
31. Procedures, Section IV., B-State Responsibilities
What does it mean when a re-rating of an IMS Listed BTU is due from a change in
status because of a "significant change in number of producers"?
FDA considers that a significant change has occurred when a 25% or higher
(increase or decrease) in the total number of producers within a BTU has
occurred.
32. SSCC, IMS Listing Requirement and Section C-Bacteriological Examination
What are the listing and sampling requirements for PET bottle manufacturers
(pre-formed at one plant and then finally molded at a second plant)?
In the second molding step, the temperature of the bottle in the neck and thread
areas may not reach high enough temperatures to destroy microorganisms. Thus
the following requirements apply:
1.) The first pre-forming plant must be listed, but sampling of the containers
is not required at this plant.
2.) If the first pre-forming plant is also molding the containers into their
final form, this plant must be listed and the containers must be sampled at this
plant.
3.) If the second plant, where containers are molded into their final form, is a
single service container manufacturer, this plant must be listed and the
containers must be sampled at this plant.
4.) If the second plant is a milk plant where containers are molded into their
final form, for use only in that milk plant, this milk plant listing is
sufficient, but the containers must be sampled at this plant.
The appropriate test, such as the rinse test, must be conducted in order to
detect any contamination in the neck of the bottle.
________________________________________________________________________________
M-I-00-08 11 December 18, 2000
