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U.S. Department of Health and Human Services

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M-I-84-4: Recent Seminar Discussions

 

HHS/PHS/FDA/CFSAN/OC/DCP/MSB
 
 
                                              200 ~C~ Street,
                                              S.W.
                                              Washington,
                                              D.C. 20204
 
                                              M-I-84-4
 
                                              April 20, 1984
 
 
To    : All Regional Food and Drug Directors
        Attn: Regional Milk Specialists
 
From  : Milk Safety Branch, HFF-346
 
Subject: Recent Seminar Discussions
 
Enclosed are copies of the questions and answers which were discussed at
Region I and II Seminar held in 1983.
 
Copies of this memorandum are enclosed for distribution to State milk
sanitation regulatory agencies and State Milk Rating Officers in your
Region.
 
 
                                  Robert L. Sanders
                                  Senior Milk Sanitation Officer
 
______________________________________________________________
 
M-I-84-4
4/20/84
Questions and Answers from the Region I and II Milk Seminar:
 
1.Q:  Does Test #22, swab and rinse procedure, cover coliform for
      single-service containers?
 
   A: Yes.
 
2.Q:  Does a submerged inlet in a stock trough at the bottom of a hill
      and downhill from the milk house need to be protected against back
      siphonage if there is no pump in the system? (gravity system)
 
   A: Each system must be evaluated individually to determine other
      unstated factors, such as the likelihood of the occasional use of a
      high pressure cleaning pump.  However, as described, this system
      would not be debited.
 
3.Q:  What if you cannot be sure if other conditions may exist which
      could affect the above system?
 
    A:Fix the submerged inlet.
 
4.Q:  Can a check-valve be used in place of a vacuum breaker to prevent
      back siphonage in a water system?
 
    A:No.
 
5.Q:  When a reinspection is requested because of low check-rating
      results, how soon after the due date must the paperwork reach
      Washington, D.C.?
 
    A:Fifteen days is the general guideline.
 
6.Q:  Are phosphatase tests required to be run on cultured products?
 
    A:Yes.
 
7.Q:  Are antibiotic tests required to be run on cultured products?
 
    A:Not at this time.
 
8.Q:  Do we rate all products by a single-service container manufacturer
      or only those used for dairy products?
 
   A: We are not required to evaluate the production of products except
      those which will be used for milk.
 
9.Q:  Are 2400 units of Vitamin A actionable when 2000 is required?
 
   A: It should be corrected but with such a small deviation voluntary
      correction should be used to achieve compliance.
 
10.Q: Where should Vitamins be added with respect to the separation of
      milk?
 
   A: Vitamins which are soluble in milkfat should be added after
      separation.  All vitamins must be added prior to pasteurization.
 
11.Q: Are there any high pressure pumps now on the market which do
      not require a low pressure cut out switch or other equivalent
      protection?
 
   A: No.  Not to our knowledge.
 
12.Q: DeLaval high pressure pumps are now being sold as needing no
      low pressure cut out switch or other protection because the pump
      will not pump without line pressure.  Can we recognize this claim
      as accurate?
 
   A: Not at this time.  It has yet to be shown that while the pump is in
      operation, if the line pressure should drop the pump will stop
      pumping while there is still positive line pressure.  If the pump
      does not stop until zero line pressure is reached, it does not meet
      the pubic health need for protection.
 
13.Q: Must an original rating of a newly constructed milk plant or dairy
      farm be debited if less than four samples are on record?
 
   A: No.  If plant has been in operation less than six months.
 
14.Q: What about an older plant or farm which has been functioning
      under a State permit previously but has recently come under the
      IMS program?
 
   A: Yes.  The four samples are required to receive the applicable
      sanitation and enforcement credit.
 
15.Q: Describe the possible approved ways to protect a single inlet pipe
      rinsing through nonpotable water in a stock trough.
 
   A: The most common methods are:
      a.   Double case the inlet pipe where it passes through the
           standing water and provide free drainage for any liquid
           accumulated between the pipes.
 
      b.   Protect the remainder of the system by placing an approved
           backflow preventer on the line to the stock trough down
           stream from the last tee which goes to any potable water
           use.
 
16.Q: Must metal cans used for pasteurized cream come from an
      approved and listed single-service source?
 
   A: Not if they are constructed of safe materials and sanitized prior to
      use.
 
17.Q: Are there any listed sources for metal cans?
 
   A: No.
 
18.Q: Does this mean that at least for now, metal cans must be sanitized?
 
   A: Yes.
 
19.Q: Must bag in box outlet valves and plastic materials used to line
      milk caps come from an approved source?
 
   A: After further consideration, MSB has concluded that these sources
      should be approved and listed.  It is not necessary for the
      component parts to be bacteriologically tested so long as they are
      included in the bacteriological test of the final assembled bag or
      cap.
 
20.Q: What standards are required to be met for the filter for the
      manhole of a tank truck during unloading in a covered but
      unenclosed area or the vent of a silo which is located in a raw milk
      receiving area?
 
   A: While there is no specific standard, we normally accept filter
      media similar to that used to filter milk.
 
21.Q: What about steel wire?
 
   A: No.  It must be single service.
 
22.Q: What about a furnace filter?
 
   A. No.
 
23.Q: What particle size are we worried about filtering out?
 
   A: The PMO does not provide specifics, but the intent is to filter out
      dust and particulate matter which may be present in the air in a
      tank truck receiving bay.
 
24.Q: Does one end of a tubular precooler have to open into a milk
      house?
 
   A: Yes.  A milk house with sufficient space for disassembly,
      inspection and manual cleaning of the precooler when necessary.
 
25.Q: Is a screen door acceptable between a barn and a milk house?
 
   A: No.  A tight-fitting, self-closing, solid door is required.
 
26.Q: What about a compressor room with only a screen door or large
      screen between it and the milk house?
 
   A: When only a screen door separates them, it is considered to be part
      of the milk house and would be evaluated as such.
 
27.Q: What about properly designed vents between a compressor room
      and a milk house?
 
   A: These are considered to be an adequate separation.
 
28.Q: Is a water line hooked up directly to the lid of a vat pasteurizer
      debitable under the PMO if the water line is not equipped with a
      leak detector valve?
 
   A: It is not debitable under Item 16p a(2)(h) (leak protector valves).
      It could be debitable under Item 15p, protection from
      contamination or Item 7p, water supply, if it is not properly
      installed and/or operated.
 
29.Q: What protection is required?
 
   A: It should not be directly connected when product is in the vat.  A
      swing elbow or other device to assure that any leakage past the last
      valve does not enter the vat and thereby adulterate the product.  If
      a submerged inlet exists, it would also be an Item 3p violation,
      unless properly protected by an air break.
 
30.Q: May a State set standards in excess of those required by the PMO?
 
   A: Yes.
 
31.Q: How do we pro-rate enforcement rating debits on sampling for
      either farms or plants?
 
   A: IMS A-18 tells us what criteria to use, but the final decision as to
      how much emphasis to give each item is a matter of professional
      judgment.
 
32.Q: Is recirculated cooling water or glycol in the head of a blow mold
      machine required to be protected and tested?
 
   A: Not unless the cooling water or glycol is also used in another
      application which does require protection.
 
33.Q: Is an air space heater required if the product temperature is 5x
      higher than the minimum pasteurization temperature?
 
   A: This question reflects a common misconception.  The actual
      requirement is that the air space above the product must be 5x
      higher than the minimum pasteurization temperature.  This may or
      may not be accomplished if the product is heated 5x above the
      minimum.
 
34.Q: Can a directly plumbed sealed water tank with no vent be used as a
      separate system to provide the required protections for a high
      pressure pump?
 
   A: No.
 
35.Q: What about if you add a vacuum breaker?
 
   A: Not unless the vacuum breaker is spring loaded and will open to
      the air while there is still positive line pressure.
 
36.Q: Is the JMO strip chart acceptable for use as a recorder controller
      chart?
 
   A: The strip chart reviewed is not satisfactory because it is not
      graduated in 1x graduations in the pasteurization range.
 
37.Q: There is an in-line ~mastitis indicator~ which consists primarily of
      a woven screen.  Where do we mark the use of this device?
 
   A: Under equipment construction.  Item 9r.
 
38.Q: What is the status of Insecta-Paint (both pre-mixed and the
      insecticide which the farmer adds to his own paint)?
 
   A: The material (Chlorpyrifos) which the farmer adds to his own paint
      is not approved by EPA for use on diary farms.  The pre-mixed
      product has recently been approved by EPA after a change in
      labeling to be used in dairy farms and other farm buildings but
      may not be used in milk rooms, milk houses or other food
      producing areas.
 
39.Q: Is acid whey required to comply with the cooling and/or the double
      surge tank (emptied and cleaned every four hours) requirement of
      the DMO?
 
   A: This requirement is intended to prevent the growth of
      staphylococcus organisms and the subsequent production of Staph.
      toxins.  Staphylococcus will seldom produce toxin at a pH of 4.7
      or less, although it may grow slowly.  Therefore, acid whey with a
      pH of less than 4.7 is not required to meet these requirements.
 
40.Q: Are rubber collars on lines from precookers to farm bulk milk
      tanks acceptable in lieu of metal collars?
 
   A: If they are made of approved materials and if they fit tightly
      enough around the cold pipe to prevent condensate from getting
      into the product.
 
41.Q: Is sodium nitrite permitted as an additive to cooling water to inhibit
      corrosion inside blow mold heads if the cooling water is used for
      other food cooling applications?
 
   A: It would appear that its use in water to cool blow mold heads
      would not be a potential problem due to the thickness of the metal
      separating the water and the blow mold chamber.  If the cooling
      water has additional plant applications such as milk t water under
      pressurized systems, there may be a potential for cross
      contamination.  The CFR does not permit sodium nitrite as an
      additive to milk.  If a dual use is desired, the manufacturer of this
      product should submit a question to FDA Center for Food Safety
      and Applied Nutrition.
 
                      Industry Session
 
1.Q:  If sweet and acid whey are mixed and the pH stays in the acid
      whey range, can the product be handled as acid whey?  (Be exempt
      from emptying the tanks every four hours when the product is in
      bacterial growth temperature ranges).
 
   A: Yes, however, it would not meet the standards of identity and the
      names as specified in those standards may not apply.
 
2.Q:  Must crystallized whey be cooled to 45x or less within 18 hours if
      not processed?
 
  A:  Yes.
 
3.Q:  Newer separators operate at 140xF.  The PMO says heat treated
      milk may not be heated above 125xF for separation, unless it is
      properly pasteurized.  Is there any exception for these new
      separations?
 
  A:  No, unless they are incorporated as part of an HTST system and
      complete pasteurization of the whole milk and/or the cream and
      skim is accomplished as part of the system.
 
4.Q:  May harmless lactic acid producing bacteria be added to raw milk
      to prevent the growth of psychrotrophic bacteria?
 
  A:  No.
 
5.Q:  What is the status of the preincubated  (PI) count?
 
  A:  The conference accepted the PI count as an alternative for the
      standard plate count.  At this time, an implementation date has not
      been set.
 
NOTE:      Since these questions were answered the NCIMS Executive
           Board has met and set an effective date of July 1, 1986,
           unless the 1985 conference elects to make changes.  FDA is
           conducting a research project in conjunction with the
           STATES to compare the PI and SPC with actual sanitary
           conditions on the farm.  This will be completed in late
           1985.  It is hoped that this study will provide additional
           data to reach a better decision on bacterial tests.
 
6.Q:  Under what conditions can water taken from milk during reverse
      osmosis be used for general equipment washing or other plant
      purposes?
 
  A:  A procedure must be developed to assure safety.  Data must be
      gathered to show that the procedure works.  Protections under this
      procedure may be very similar to those already approved protection
      needed for water removed from milk in condensers.