U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
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 ro 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
judgement.
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.
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