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M-I-85-12: Regions VIII, IX, X milk Seminar Questions and Answers

 

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
       judgment 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 judgment 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 judgment 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 judgment 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 judgment 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 judgment 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 judgment and
       common sense must prevail in making these determinations.