U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
M-I-85-12 - Regions VIII, IX, X Milk Seminar Q&A
HHS/PHS/FDA/CFSAN/OC/DCP/MSB
200 C Street, S.W.
Washington, D.C. 20204
M-I-85-12
September 4, 1985
TO: All Regional Food and Drug Directors
ATTN: Regional Milk Specialists
FROM: Milk Safety Branch, HFF-346
SUBJECT: Regions VIII, IX, X milk Seminar Questions and Answers
Enclosed are copies of the questions and answers which were discussed at
the Regions VIII, IX, and X Milk Seminar held October 23-25, 1984 in
Carson City, Nevada.
Copies of this memorandum are enclosed for distribution to State milk
sanitation regulatory agencies and State Milk Rating Officers in your
Region.
Stephen L. James
Senior Milk Sanitation Officer
Milk Safety Branch, HFF-346
Division of Cooperative Programs
Center for Food Safety and Applied
Nutrition
______________________________________________________________
Regions VIII, IX, X - Annual Regional Milk Seminar - Questions and
Answers
Carson City, Nevada, October 23-25, 1984
Q.1. Cow lots for non-lactating animals. Since cow treatment and
handling are critical in the cure and prevention of mastitis, and
especially where the 'dry cow' lot is in immediate association and
proximity of the lactating animals, I think we need more emphasis
on this other than flybreeding. Where do you mark these
violations on the inspection form?
A. Item 4r includes areas adjacent to the barn including cattle housing
areas and feed lots utilized by the lactating herd. Professional
judgement must dictate if this is a violation of Item 4r, 21r(a) or
21r(g). Item 21r(a) should be debited only if conditions are such
that insect breeding is evident. Item 21r(g) should be debited when
surroundings are found not to be neat and clean and free of insect
and rodent harborages.
Q.2. What is an adequate hot water supply? How hot should the water
be, capacity, etc? Shouldn't we have some guideline figures at
least suggested?
A. Guidelines for hot water are presently found on page 92, Appendix
A of the PMO. Other guidance for hot water requirements may be
found in the 3-A Accepted Practices (#606-02) and under general
guidance and direction provided by dairy detergent manufacturers.
Q.3. Has there been a decision made by FDA regarding the ultra
filtration of raw milk would result in an end product for which no
standard of identity has been established. Further research and
information has been requested from industry concerning this
process.
A. At this time FDA's position is that the ultra filtration of raw milk
would result in an end product for which no standard of identity
has been established. Further research and information has been
requested from industry concerning this process.
Q.4. Are agitator CIP shafts approved in farm bulk milk tanks? Many
are not used and the spray ball on the inside of the tank will collect
milk stone, protein, etc., and are never washed.
A. Yes, the farm tanks with built-in CIP units were found acceptable
by both FDA and the 3-A Standard Committee except for those
shafts with non-inspectable dead-ends that are not acceptable.
Tanks provided with acceptable CIP type of units should utilize the
CIP as designed to prevent problems associated with non-use.
Q.5. I have a well pit with a well casing that extends 3 feet above the
ground level. Does this pit need a sump pump, cement floor, etc.?
A. Yes, this pit would have to meet all requirements as outlined in
Appendix D of the PMO.
Q.6. What authority do some milk specialists have to carry PMO
interpretations beyond the word of the ordinance?
Example - marking locations of hand washing facilities if not
convenient.
A. Milk specialist have no authority to carry PMO interpretation
beyond the word of the ordinance. Location of hand washing
facilities is a professional judgement item and must be determined
by all inspectors including milk specialists for each individual
circumstance.
Q.7. Why are points deducted on surveys and check ratings because the
milk specialist or survey officer does not personally comprehend
the system in use, as long as the data is available on request from
the technician in charge?
A. Provisions for all regulatory records including computer records
are included in the ordinance. The data should be readily
accessible, neat, organized and provide the necessary information,
not only to perform an enforcement rating, but also be able to
provide the regulatory agency with the required information.
Q.8. How sound of legal ground are we on with some of the violations
that by reasonable review are not actually in violation of the
wording of the PMO?
i.e., -hose in sink marked as submerged
-inconveniently placed hand-sink
-any other such item?
A. Many items in the PMO are not clearly stated as violations,
however, professional judgement and interpretations as determined
by standardizations must be routinely utilized to determine
debitable code violations.
Q.9. Where do you debit a HTST system which has a regenerator by-
pass linkage which is not close coupled?
A. This situation would be in violation of Item 10(p) (a) (deadends) in
the ordinance.
Q.10. Are rigid clear plastic lines approved for use in a dairy farm back
flush system?
A. Since the lines in question would be used to convey iodine and/or
water solution only, there would be no objection to using clear
plastic lines that are nontoxic and would not deteriorate under
normal usage.
Q.11. The 3-A Standards require a vacuum breaker on the line to the
flow diversion valve when the line is permanently mounted on the
CLT below the flood rim. What types of vacuum breakers are
acceptable?
A. We were unable to locate this requirement in the 3-A Standards nor
confirm that the PMO has such a requirement. A direct line
entering the balance (CLT) tank below normal operating levels
would be in violation of the ordinance Item 16(b) (2) (a) and the
leak detection line must have a site glass if the line is connected
direct to the CLT.
Q.12. When recirculation lines are mounted on the pasteurized side of the
HTST below the air gap plumbed into the CLT, do they require an
air gap or vacuum breaker?
A. Yes. The ordinance requires that the pasteurized product, between
its outlet from the regenerator and the nearest point downstream
open to the atmosphere, shall rise to a vertical elevation of 12
inches above the highest raw product level... and shall be open to
the atmosphere at this point or higher... The above described
situation would therefore be in violation of this requirement
according to the PMO. We are aware, however, that there is a
provision for this found in the 3-A Sanitary Practices, for HTST
systems, paragraph E.9.2. This by-pass valve, when installed in
the horizontal pasteurized product line at least 12" above any raw
milk in the system, or may be installed in the recommended
downstream position. (See figures 6 and 7 of the HTST 3-A
Sanitary Practices).
Q.13. Are silicon liners (inflations) approved for in-place cleaning?
A. We have not previously received comments about the CIP cleaning
problem associated with these type of liners; however, any cleaning
or usage problems discovered in the field should be documented
and reported to the Regional Milk Specialist and forwarded to the
Milk Safety Branch.
Q.14. What is FDA's position on wells that meet coliform requirements,
but are high in other contaminants, such as nitrate and iron?
A. The Ordinance currently establishes coliform standards for water
supplies as established in Appendix G. Reference, however, is
made in this Appendix to Items 8r, 19r, 7p and 17p, which
requires the water supply be approved as safe by the State water
control authority. If the State has chemical standards for nitrates,
iron, etc., then these standards should be met. The PMO does not
require the additional tests to be run, however, if the tests are
conducted, the supply must meet the State Water Control Authority
standards.
Q.15. Is there a probationary status for BTU's that do not meet survey or
Check Rating requirements?
A. No. Current NCIMS 'Procedures' manual has no provision for a
probationary status for listed BTU's requiring immediate removal
from the IMS list.
Q.16. Is flexible tubing acceptable for external gauges on farm bulk
tanks?
A. Yes, as long as they meet construction criteria and are nontoxic.
Please remember that provisions require that all milk entering these
measuring tubes must be discarded.
Q.17. Is it permissible to open a manhole cover on a tanker while picking
up milk at a farm?
A. No. The opening of manhole covers on a tanker filled with milk at
a location, other than a plant, receiving, or transfer station, is
prohibited for obvious reasons (flies, dust, etc.).
Q.18. Where is the proper location of a magnetic flow meter in relation
to the holding tube of the HTST unit?
A. Upstream from the holding tube, and downstream from the last
flow promoting device.
Q.19. What are the requirements for using a strip chart on HTST unit?
A. Strip charts, which may be used for any type of milk processing,
must contain all the same information presently required on
circular charts, as so indicated in Item 16p(E). The only exception
for strip charts is found in Appendix H allowing for showing a
continuous recording over a 24 hour period.
Q.20. What are the labeling requirements for UHT pasteurized products?
A. The Ordinance does not define UHT Pasteurized products. If the
question is referring to labeling of Aseptic processed and packaged
products to be stored at room temperature, 'UHT Long Shelf Life'
must precede the name of the milk product and the words 'keep
refrigerated after opening' must appear on the label. If the
question is referring to ultra pasteurized products, then the term
'ultra pasteurized' shall be used when the products are processed
at or above 280x for at least 2 seconds.
Q.21. Under No. 7r 'Toilet', which items are debited under 7r(b) and
which items are debited under 7r(d)?
A. Item 7r(d) is debited when unclean conditions are found, doors not
self-closing, tight fitting, etc. Improper physical construction of
the toilet room would be a violation of item 7r(b).
Q.22. On a Richie waterer, why is double casing needed on a plastic riser
pipe since it will not rust, and if it does leak, it will flood the
reservoir and the cow yard and consequently cause a producer to
cut off the water supply prior to back siphonage.
A. If any piping is located or submerged in non-potable water, this is
considered a potential cross-connection between safe and unsafe
water and is a violation of Item 8r(c), unless the line is a double
line.
Q.23. Sanitary traps--if the trap is not part of the CIP system and is
installed properly with down sloping lines to the trap, why
wouldn't an unclean trap be debited under 6r(a). 'Non-product
Contact surface.' Airflow during milking is directed away from the
milk receiver and bulk tank and toward the vacuum pump. When
not milking, the only contamination which can result from the trap
is airborne and that potential exists for the pipeline and receiver jar
since this system is not designed to be airtight. Also, sanitizing
prior to milking should kill any airborne contamination from the
trap.
A. There still remains the common connection between the trap and
the receiver jar whereby air and odors can intermingle with
product. If the traps are not clean, this is a violation of Item
10r(a). Item 6r refers to non-product areas such as walls, floors,
exterior of equipment, etc.
Q.24. Is a milk pipeline that is covered with whitewash debitable under
Item 3r(a), 'Cleanliness?' The reason being it is not an easily
cleanable surface.
A. We do not believe it is a good practice to paint or cover milk lines
in the barn. If the line is painted with a cleanable, light colored
paint, non toxic, and maintained in good repair (no chipping,
pealing, etc.), we would not debit this item on a check rating.
Professional judgement must be used in these cases.
Q.25. In reading the administrative procedures in the PMO, it appears
that in a stanchion barn or flat barn, either water must be used to
clean the alleys or brushing and liming must be done. If no
evidence of liming can be found and the water is not available in
the barn, would Item 3r(a) be debited by the inspector? State
survey officer?
A. As this item states, the method of cleaning is immaterial.
Procedures and guidelines are also provided under Item 3r(a) when
barn floors. You can only debit Item 3r(a) when barn floors are
unclean, irregardless of whether or not there is water available in
the barn for cleaning.
Q.26. Would the ruling on accessibility for inspection, (where a tool
located in the milk room meets the requirements of accessibility),
also apply to mounted racks in double-vat sinks that are easily
removable through the use of a tool located in the milk room?
Why would that not meet the requirements of Item r, 'Cleaning
Facilities-a?' The PMO states, 'The cleaning-in-place station rack
in or on the vat and the milking machine inflations and appurtances
are completely removed from the vat during the washing, rinsing
or sanitizing of other utensils and equipment.' It does not refer to
the degree of difficulty in removing the racks.
A. The rack(s) should be completely removed during manual washing,
rinsing or sanitizing of other utensils and equipment. If the racks
are permanently attached to the wash vat and are not removable
and there is only one two-compartment wash vat present, then Item
r(a) Cleaning Facilities is debited. The difficulty of removing the
wash rack is not dealt with in this item, however, good
professional judgement must be exercised. The requirement (or
provision) for disassembly tools to be located at the milk house,
deals only with milk contact surfaces.
Q.27. What is the proper method to handle an enforcement agency's
policy of sending out double violation notices on an item 2r(b), for
example) only when the exact problem is debited twice, (i.e., west
wall needs painting). If two different walls of the same parlor are
debited on two consecutive inspections, no double violations notice
is sent. Is this an enforcement violation or not?
A. Section 3 - Permits, specifies that when any requirement(s) of the
Ordinance is violated, the permit holder may have his permit
suspended. Section 5 - Inspections, requires that should the
violation of any requirement set for in Section 7 (body of the
PMO) be found, a second inspection is required (after 3 days) to
determine compliance. A violation on this second inspection calls
for permit suspension in accordance with Section 3 (Permit
Suspension). To answer your question, consecutive violation on
barn wall construction under Item 2r(b) (section 7) requires
enforcement action, irregardless of which specific wall was
improperly constructed. Professional judgement of the rating
officer must dictate if this is a consecutive violation.
Q.28. On an artesian free-flowing well with pressure of approximately
50psi, if a hose is lying in the bottom of a stock tank and still
connected to the field hydrant, would this be a debit under 8r(c)?
Why? (Only well on farm)
A. In most instances (depending upon the circumstances) submerged
inlets at any point in the distribution systems is debited under Item
8r(c). However, each individual system must be evaluated
thoroughly to determine other unstated hydrostatic factors (such as
pumps in the system, high pressure wash down pumps, reservoirs
and their location, etc.). You should also consider other
influencing factors affecting distribution line pressures such as age
of well (has pressure weakened over a period of time), increased
water demand on the unit (added on more equipment, etc.) Which
places greater demand on the system, or other influencing factors.
When in doubt, it is recommended all water inlets be installed
above the overflow rim of the vessel containing the non-potable
source. It may still be possible to get a venturi effect and
contaminate other water lines.
Q.29. Where does the PMO define what materials can be used for a
double-vat sink? Item 9r makes reference to multi-use containers
used in handling, storage, or transportation of milk. The double-
vat sinks are not used for any of these and, therefore, it appears to
be excluded. In reviewing the 3-A standards under 606-02, 3A
Accepted Practices for the Design, Fabrication and Installation of
Milking and Milk Handling Equipment, Item No. C.4, seems to
refer to double-vat sinks. However, the connection with double-vat
sinks in this item is not completely clear.
A. Item 9r deals only with the construction requirements for milk
contact surfaces, those surfaces to which milk is exposed or may
drip, drain, or be drawn. Utensils wash vats should be relatively
smooth and be of sufficient size to accommodate the largest utensil
or container that is washed manually. When wash vats deteriorate
to a condition of poor repair (i.e., excessive corrosion, separated
seams, etc.) Which hampers their intended use, then Item 5r(a)
(Cleaning Facilities) would be debited. Good judgement and
common sense must prevail in making these determinations.
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